A Phase 1/2 interventional study of INCB001158 and Oxaliplatin in Biliary Tract Cancer (BTC), Colorectal Cancer (CRC) and Endometrial Cancer, sponsored by Incyte Corporation. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Incyte Corporation · Phase 1/2, Interventional, and Treatment
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Among 155 studies in Biliary Tract Neoplasms with a site in United States — 48 open to participants now, 67 under way, 9 of them phase 3. Biliary Tract Neoplasms · United States.
Among the 155 studies in Biliary Tract Neoplasms with a site in United States, this one is the 50th largest by enrollment of the 140 interventional ones that give a count, is one of 7 that started in 2017, is one of 31 in phase 1/2, and was the 55th registered.
519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.
Browse Biliary Tract Neoplasms studies →48 of the 155 studies in Biliary Tract Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Crescent Biopharma, Inc. · Sites in United States
Ages 18+
AbbVie · Sites in United States
Ages 18+
SK Life Science, Inc. · Sites in United States, Korea, Republic of
Ages 18+
InnoPharmax Inc. · Sites in United States, Taiwan
Ages 18+
J-Pharma Co., Ltd. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 140 Biliary Tract Neoplasms studies recruiting now, 80 (57%) set no upper age limit and 37 (26%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 64 · Phase 2 85 · Phase 3 14
First in 2002; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 149 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Median enrollment 75 across the 140 interventional studies, 135 across the 14 observational. Of the 80 that completed or were terminated, 48 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
86 of 155 have an industry lead sponsor. The 10 most frequent:
Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Incyte Corporation has 1 study filed under Biliary Tract Neoplasms — fewer than ten, so there is no comparison to draw.
20 of the studies in Biliary Tract Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05506943Phase 3Compass TherapeuticsA Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002) | 2027-08-31 |
| NCT07265674Phase 3J-Pharma Co., Ltd.A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer | 2027-10 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT06451497Zumutor Biologics Inc.This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors | 2026-12 |
Add all 20 to your calendar (.ics) → With an account.
Among the 155 studies in Biliary Tract Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INCB001158 + FOLFOX
Drug: INCB001158 · Drug: Oxaliplatin · Drug: Leucovorin · Drug: 5-Fluorouracil
INCB001158 + gemcitabine/cisplatin
Drug: INCB001158 · Drug: Gemcitabine · Drug: Cisplatin
INCB001158 + paclitaxel
Drug: INCB001158 · Drug: Paclitaxel
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Also known as: Arginase inhibitor
Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
Leucovorin at the protocol-defined dose and regimen.
5-Fluorouracil at the protocol-defined dose and regimen.
Gemcitabine at the protocol-defined dose and regimen.
Cisplatin at the protocol-defined dose and regimen.
Paclitaxel at the protocol-defined dose and regimen.
Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Time frame: up to 1385 days
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.
Time frame: up to Day 28
Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen
The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.
Time frame: up to Day 580
Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.
Time frame: up to 1385 days
Phase 1: ORR
ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions.
Time frame: up to 580 days
Phases 1 and 2: Duration of Response
DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Time frame: up to 368 days
Phases 1 and 2: Disease Control Rate
DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Time frame: up to 1385 days
Phases 1 and 2: Progression-free Survival
According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.
Time frame: up to 1385 days
Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration
Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Time frame: Day 1 of Cycle 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycle 2: predose; 1 and 4 hours post-dose for sparse sample collection
Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
| Milestone | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 8 | 6 | 6 | 7 | 4 | 4 | 7 | 5 | 7 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 8 | 6 | 6 | 7 | 4 | 4 | 7 | 5 | 7 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 4 | 2 | 5 | 4 | 3 | 4 | 5 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 1 | 2 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Progressive disease | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Captured as "other" in database | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 33 | 9 | 11 | 10 | 24 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 33 | 9 | 11 | 10 | 24 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 20 | 6 | 7 | 6 | 17 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 1 | 0 | 1 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 2 | 1 | 4 | 4 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
| Participants | Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel |
|---|---|---|---|---|---|---|---|---|---|
| Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 8 | 6 | 13 | 7 | 4 | 46 | 7 | 5 | 51 |
A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.
| Participants | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.
| milligrams | All Phase 1 Participants |
|---|---|
| Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen | 100 |
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.
| percentage of participants | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|
| Phase 2: Objective Response Rate (ORR) | 0.0 (0.0 to 36.9) | 24.2 (11.1 to 42.3) | 22.2 (2.8 to 60.0) | 9.1 (0.2 to 41.3) | 30.0 (6.7 to 65.2) | 16.7 (4.7 to 37.4) |
ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the Baseline sum diameters, no new lesions, and no progression of non-target lesions.
| percentage of participants | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel |
|---|---|---|---|---|---|---|---|---|---|
| Phase 1: ORR | 12.5 (0.3 to 52.7) | 0.0 (0.0 to 45.9) | 0.0 (0.0 to 45.9) | 0.0 (0.0 to 41.0) | 25.0 (0.6 to 80.6) | 0.0 (0.0 to 60.2) | 14.3 (0.4 to 57.9) | 0.0 (0.0 to 52.2) | 28.6 (3.7 to 71.0) |
DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
| months | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phases 1 and 2: Duration of Response | — | — | — | — | — | — | — | — | — | — | 5.8 (4.1 to NA) | — | — | — | — |
DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
| percentage of participants | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phases 1 and 2: Disease Control Rate | 62.5 (24.5 to 91.5) | 83.3 (35.9 to 99.6) | 16.7 (0.4 to 64.1) | 57.1 (18.4 to 90.1) | 75.0 (19.4 to 99.4) | 100.0 (39.8 to 100.0) | 42.9 (9.9 to 81.6) | 60.0 (14.7 to 94.7) | 85.7 (42.1 to 99.6) | 100.0 (63.1 to 100.0) | 66.7 (48.2 to 82.0) | 88.9 (51.8 to 99.7) | 54.5 (23.4 to 83.3) | 80.0 (44.4 to 97.5) | 66.7 (44.7 to 84.4) |
According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.
| months | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phases 1 and 2: Progression-free Survival | 3.7 (1.8 to 3.9) | 6.6 (1.7 to NA) | 1.7 (1.6 to NA) | 3.9 (0.6 to NA) | 5.3 (NA to NA) | 6.4 (3.7 to NA) | 3.9 (0.8 to NA) | 3.7 (1.5 to NA) | 11.8 (1.7 to 16.1) | 3.7 (2.8 to NA) | 8.5 (5.7 to 10.1) | 7.8 (2.2 to NA) | 3.5 (1.7 to NA) | 7.1 (3.5 to 11.1) | 3.7 (2.4 to 4.9) |
Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
| nanograms per milliliter (ng/mL) | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|
| Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration | 747 ± 35.7 | 407 ± 407 | 268 ± 888 | 542 ± 102 | 1020 ± 27.2 | 633 ± 131 |
Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
| ng/mL | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1290 ± 16.4 | 1350 ± 35.2 | 2160 ± 22.3 | 1100 ± 68.0 | 1760 ± 17.2 | 1640 ± 23.2 |
| Cycle 2 Day 1 | 1960 ± 12.6 | 1860 ± 46.7 | 2250 ± 26.4 | 1600 ± 22.0 | 2390 ± 11.4 | 2100 ± 24.6 |
tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
| hours | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 4.13 (2.00 to 6.10) | 4.07 (1.97 to 7.53) | 4.08 (3.67 to 6.00) | 5.05 (2.25 to 7.50) | 4.09 (2.00 to 6.17) | 3.97 (1.78 to 6.08) |
| Cycle 2 Day 1 | 4.00 (1.80 to 7.50) | 4.00 (0.983 to 7.53) | 4.06 (2.03 to 6.02) | 4.13 (1.92 to 7.53) | 3.85 (3.77 to 3.92) | 3.95 (2.03 to 6.00) |
AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
| hours x ng/mL | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 6910 ± 17.6 | 7240 ± 32.9 | 10600 ± 18.9 | 4680 ± 134 | 9290 ± 33.2 | 8840 ± 24.7 |
| Cycle 2 Day 1 | 11000 ± 21.1 | 10600 ± 55.3 | 12200 ± 34.4 | 10000 ± 18.4 | 14400 ± 13.7 | 12800 ± 30.3 |
tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
| hours | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) |
|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 7.53 (7.47 to 8.00) | 7.73 (6.00 to 8.42) | 7.53 (7.50 to 8.05) | 7.50 (3.50 to 8.08) | 7.53 (7.50 to 7.67) | 7.65 (5.73 to 8.15) |
| Cycle 2 Day 1 | 7.50 (6.00 to 7.57) | 7.58 (7.50 to 8.38) | 7.60 (7.50 to 8.25) | 7.57 (7.50 to 8.00) | 7.55 (7.50 to 7.67) | 7.58 (7.48 to 8.25) |
Collected over up to 1385 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | 4/8 (50%) | 6/8 (75%) | 8/8 (100%) |
| Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | 2/6 (33.3%) | 1/6 (16.7%) | 6/6 (100%) |
| Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | 11/14 (78.6%) | 7/14 (50%) | 13/14 (92.9%) |
| Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | 4/7 (57.1%) | 3/7 (42.9%) | 7/7 (100%) |
| Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | 3/4 (75%) | 1/4 (25%) | 4/4 (100%) |
| Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | 30/46 (65.2%) | 30/46 (65.2%) | 45/46 (97.8%) |
| Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | 5/7 (71.4%) | 4/7 (57.1%) | 7/7 (100%) |
| Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | 4/5 (80%) | 4/5 (80%) | 5/5 (100%) |
| Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel | 36/52 (69.2%) | 27/52 (51.9%) | 50/52 (96.2%) |
| Total | 99/149 (66.4%) | 83/149 (55.7%) | 145/149 (97.3%) |
| Event | Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| AscitesGastrointestinal disorders | 0/8 | 0/6 | 0/14 | 1/7 | 0/4 | 0/46 | 3/7 | 0/5 | 3/52 | 7/149 |
| DehydrationMetabolism and nutrition disorders | 0/8 | 0/6 | 0/14 | 0/7 | 1/4 | 1/46 | 1/7 | 0/5 | 3/52 | 6/149 |
| VomitingGastrointestinal disorders | 2/8 | 0/6 | 0/14 | 0/7 | 1/4 | 7/46 | 0/7 | 0/5 | 2/52 | 12/149 |
| Cancer painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/8 | 0/6 | 0/14 | 0/7 | 0/4 | 0/46 | 0/7 | 1/5 | 0/52 | 1/149 |
| CholangitisHepatobiliary disorders | 0/8 | 0/6 | 1/14 | 0/7 | 0/4 | 0/46 | 0/7 | 1/5 | 0/52 | 2/149 |
| General physical health deteriorationGeneral disorders | 0/8 | 0/6 | 0/14 | 0/7 | 0/4 | 1/46 | 0/7 | 1/5 | 2/52 | 4/149 |
| Intestinal obstructionGastrointestinal disorders | 0/8 | 0/6 | 0/14 | 0/7 | 0/4 | 0/46 | 1/7 | 1/5 | 1/52 | 3/149 |
| Brain oedemaNervous system disorders | 0/8 | 1/6 | 0/14 | 0/7 | 0/4 | 0/46 | 0/7 | 0/5 | 0/52 | 1/149 |
| Confusional statePsychiatric disorders | 0/8 | 1/6 | 0/14 | 0/7 | 0/4 | 1/46 | 0/7 | 0/5 | 0/52 | 2/149 |
| Haemorrhage intracranialNervous system disorders | 0/8 | 1/6 | 0/14 | 0/7 | 0/4 | 0/46 | 0/7 | 0/5 | 0/52 | 1/149 |
| Event | Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 | Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel | Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel | Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders | 3/8 | 4/6 | 4/14 | 1/7 | 1/4 | 23/46 | 2/7 | 4/5 | 29/52 | 71/149 |
| AnaemiaBlood and lymphatic system disorders | 4/8 | 2/6 | 2/14 | 5/7 | 2/4 | 25/46 | 2/7 | 1/5 | 21/52 | 64/149 |
| Platelet count decreasedInvestigations | 1/8 | 3/6 | 2/14 | 5/7 | 0/4 | 14/46 | 0/7 | 1/5 | 3/52 | 29/149 |
| White blood cell count decreasedInvestigations | 2/8 | 1/6 | 0/14 | 5/7 | 1/4 | 8/46 | 0/7 | 0/5 | 11/52 | 28/149 |
| NauseaGastrointestinal disorders | 5/8 | 3/6 | 5/14 | 1/7 | 1/4 | 25/46 | 3/7 | 3/5 | 21/52 | 67/149 |
| VomitingGastrointestinal disorders | 3/8 | 1/6 | 3/14 | 1/7 | 1/4 | 14/46 | 1/7 | 3/5 | 18/52 | 45/149 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/8 | 0/6 | 0/14 | 2/7 | 1/4 | 8/46 | 4/7 | 0/5 | 7/52 | 23/149 |
| Neutrophil count decreasedInvestigations | 4/8 | 1/6 | 0/14 | 4/7 | 0/4 | 15/46 | 0/7 | 1/5 | 9/52 | 34/149 |
| ConstipationGastrointestinal disorders | 2/8 | 1/6 | 2/14 | 0/7 | 2/4 | 19/46 | 1/7 | 1/5 | 13/52 | 41/149 |
| DiarrhoeaGastrointestinal disorders | 3/8 | 3/6 | 6/14 | 2/7 | 0/4 | 11/46 | 3/7 | 1/5 | 16/52 | 45/149 |
| Age, Continuous(years) | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 56.4 ± 10.80 | 60.3 ± 9.93 | 65.2 ± 7.99 | 54.0 ± 18.93 | 64.5 ± 16.82 | 54.0 ± 15.64 | 62.0 ± 14.57 | 47.4 ± 10.29 | 61.4 ± 6.95 | 62.8 ± 11.26 | 59.3 ± 12.74 | 65.3 ± 8.87 | 58.8 ± 11.90 | 62.3 ± 9.29 | 60.6 ± 9.04 | 59.93 ± 11.66 |
| Sex: Female, Male(Participants) | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 4 | 3 | 3 | 2 | 3 | 5 | 4 | 5 | 3 | 21 | 9 | 4 | 10 | 24 | 103 |
| Male | 5 | 2 | 3 | 4 | 2 | 1 | 2 | 1 | 2 | 5 | 12 | 0 | 7 | 0 | 0 | 46 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 6 |
| Not Hispanic or Latino | 5 | 5 | 6 | 6 | 4 | 4 | 7 | 5 | 7 | 7 | 29 | 7 | 11 | 10 | 23 | 136 |
| Unknown or Not Reported | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 1 | 7 |
| Race/Ethnicity, Customized(Participants) | Phase 1: INCB001158 50 mg + mFOLFOX6 | Phase 1: INCB001158 75 mg + mFOLFOX6 | Phase 1: INCB001158 100 mg + mFOLFOX6 | Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin | Phase 1: INCB001158 50 mg + Paclitaxel | Phase 1: INCB001158 75 mg + Paclitaxel | Phase 1: INCB001158 100 mg + Paclitaxel | Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) | Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) | Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) | Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) | Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| White | 2 | 6 | 6 | 6 | 3 | 4 | 7 | 5 | 5 | 7 | 31 | 8 | 8 | 8 | 23 | 129 |
| Black/African-American | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 6 |
| Asian | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 1 | 7 |
| American-Indian/Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| East Indian | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Not Provided/Specified | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 3 |
| Black/Carribean | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Captured as Hispanic/Latino in Database | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Data sharing details ↗ · www.incyte.com
Ran from Nov 2017 to primary completion in Nov 2022, 60 months.
Results were first posted in Dec 2023, 1 year after primary completion.
Of 48 phase 1/2 interventional studies under Biliary Tract Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 68. This study's 60 months is close to that.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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