A Phase 1/2 interventional study of INCAGN01949 in Advanced Malignancies and Metastatic Cancer, sponsored by Incyte Biosciences International Sàrl. Completed at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Incyte Biosciences International Sàrl (part of Incyte Corporation) · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's enrollment of 87 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Incyte Biosciences International Sàrl is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
First submitted after Incyte Biosciences International Sàrl became part of Incyte Corporation.
Counted across the registry records on this site, refreshed daily.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Drug: INCAGN01949
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: From screening through 60 days after end of treatment, up to 11 months
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Objective Response Rate Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks,up to 11 months
Duration of Response Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Progression-free Survival Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Duration of Disease Control Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Time frame: Baseline and every 8 weeks, up to 11 months
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
The study was conducted at 4 different sites in US, 1 site in Switzerland,1 site in Spain and 2 sites in the United Kingdom.
| Milestone | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Started | 4 | 4 | 22 | 18 | 23 | 12 | 4 |
| Completed | 0 | 0 | 5 | 2 | 4 | 5 | 1 |
| Not completed | 4 | 4 | 17 | 16 | 19 | 7 | 3 |
| Withdrew: Other | 1 | 2 | 4 | 1 | 3 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 2 | 8 | 10 | 12 | 3 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 3 | 0 | 1 | 1 | 0 |
| Withdrew: Death | 1 | 0 | 2 | 4 | 2 | 3 | 0 |
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
| ng/ml | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma | 1630 ± 735 | 5820 ± 324 | 22300 ± 32800 | 39200 ± 10300 | 84900 ± 76700 | 207000 ± 45500 | 347000 ± 130000 |
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
| ug*hr/mL | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| cycle 1 | 185 ± 81.7 | 904 ± 197 | 2370 ± 841 | 5400 ± 1820 | 10000 ± 5600 | 28300 ± 7720 | 61600 ± 9130 |
| cycle 6 | 427 ± 9.21 | — | 5490 ± 1560 | 10700 ± 6560 | — | — | — |
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
| Participants | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Objective Response Rate Per RECIST and Modified RECIST | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
| days | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Duration of Response Per RECIST and Modified RECIST | — | — | — | — | — | 192 ± 192 | — |
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
| Days | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Progression-free Survival Per RECIST and Modified RECIST | 57 ± 55 | 47.5 ± 29 | 54.0 ± 23 | 56.0 ± 26 | 52.0 ± 1 | 125.0 ± 21 | 46.5 ± 42 |
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
| Days | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Duration of Disease Control Per RECIST and Modified RECIST | 0 (0 to 0) | 57 (57 to 57) | 64 (1 to 160) | 57 (1 to 225) | NA (1 to 112) | 120 (1 to 249) | — |
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
| Participants | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 4 | 4 | 21 | 17 | 22 | 11 | 4 |
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
| hr | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| cycle 1 | 0.64 (0.6 to 4.4) | 2.53 (0.55 to 4.5) | 4.3 (0.50 to 25.2) | 0.63 (0.5 to 4.5) | 0.6 (0.0 to 194) | 0.7 (0.53 to 4.2) | 0.73 (0.0 to 2.43) |
| cycle 6 | 0.78 (0.75 to 0.8) | — | 0.63 (0.50 to 4.3) | 0.61 (0.55 to 4.8) | — | — | — |
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
| ng/mL | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| cycle 2 | 303 ± 202 | 1890 ± 1570 | 3620 ± 1550 | 8880 ± 4510 | 17000 ± 8040 | 41000 ± 13000 | 117000 ± 19300 |
| cycle 3 | 753 ± 163 | 1520 ± 225 | 5620 ± 3280 | 14300 ± 7740 | 29400 ± 18400 | 77800 ± 27900 | 163000 ± 32900 |
| cycle 4 | 895 ± 80.2 | 1780 ± 318 | 5110 ± 2850 | 17900 ± 13200 | 42200 ± 28500 | 84600 ± 17700 | 282000 ± 165000 |
| cycle 6 | 785 ± 39.6 | — | 9150 ± 2420 | 19600 ± 13100 | 43400 ± 26500 | — | — |
| cycle 7 | — | — | 10200 ± 2190 | 21600 ± 10600 | — | — | — |
Collected over From screening through 60 days after end of treatment, up to 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 1/4 (25%) | 1/4 (25%) | 4/4 (100%) |
| PART 1 Dose 2 (20 mg) | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| PART 1 Dose 3 (70 mg) | 2/22 (9.1%) | 8/22 (36.4%) | 21/22 (95.5%) |
| PART 1 Dose 4 (200 mg) | 4/18 (22.2%) | 9/18 (50%) | 17/18 (94.4%) |
| PART 1 Dose 5 (350 mg) | 2/23 (8.7%) | 9/23 (39.1%) | 22/23 (95.7%) |
| PART 1 Dose 6 (700 mg) | 3/12 (25%) | 5/12 (41.7%) | 10/12 (83.3%) |
| PART 1 Dose 7 (1400 mg) | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Event | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| JaundiceHepatobiliary disorders | 0/4 | 0/4 | 0/22 | 0/18 | 0/23 | 0/12 | 1/4 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/4 | 0/4 | 1/22 | 1/18 | 2/23 | 3/12 | 0/4 |
| Pneumonia streptococcalInfections and infestations | 0/4 | 1/4 | 0/22 | 0/18 | 0/23 | 0/12 | 0/4 |
| Abdominal painGastrointestinal disorders | 0/4 | 0/4 | 1/22 | 0/18 | 1/23 | 2/12 | 0/4 |
| Small intestinal obstructionGastrointestinal disorders | 0/4 | 0/4 | 0/22 | 2/18 | 2/23 | 0/12 | 0/4 |
| Abdominal pain upperGastrointestinal disorders | 0/4 | 0/4 | 0/22 | 0/18 | 0/23 | 1/12 | 0/4 |
| Cauda equina syndromeNervous system disorders | 0/4 | 0/4 | 0/22 | 0/18 | 0/23 | 1/12 | 0/4 |
| EmbolismVascular disorders | 0/4 | 0/4 | 0/22 | 0/18 | 1/23 | 1/12 | 0/4 |
| PainGeneral disorders | 0/4 | 0/4 | 0/22 | 0/18 | 0/23 | 1/12 | 0/4 |
| Urinary tract painRenal and urinary disorders | 0/4 | 0/4 | 0/22 | 0/18 | 0/23 | 1/12 | 0/4 |
| Event | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) |
|---|---|---|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/4 | 3/4 | 3/22 | 1/18 | 1/23 | 1/12 | 0/4 |
| Decreased appetiteMetabolism and nutrition disorders | 1/4 | 3/4 | 6/22 | 4/18 | 7/23 | 3/12 | 0/4 |
| AnaemiaBlood and lymphatic system disorders | 0/4 | 0/4 | 4/22 | 2/18 | 1/23 | 2/12 | 2/4 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/4 | 2/4 | 2/22 | 3/18 | 3/23 | 2/12 | 2/4 |
| Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders | 0/4 | 0/4 | 1/22 | 1/18 | 0/23 | 2/12 | 2/4 |
| FatigueGeneral disorders | 2/4 | 2/4 | 6/22 | 7/18 | 8/23 | 4/12 | 2/4 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/4 | 2/4 | 0/22 | 1/18 | 0/23 | 1/12 | 0/4 |
| PyrexiaGeneral disorders | 0/4 | 2/4 | 1/22 | 0/18 | 2/23 | 1/12 | 1/4 |
| Weight decreasedInvestigations | 2/4 | 1/4 | 0/22 | 2/18 | 2/23 | 0/12 | 0/4 |
| ConstipationGastrointestinal disorders | 1/4 | 1/4 | 4/22 | 6/18 | 4/23 | 1/12 | 1/4 |
| Age, Continuous(years) | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | Total |
|---|---|---|---|---|---|---|---|---|
| Geometric mean | 54.3 ± 16.24 | 63.8 ± 12.63 | 56.8 ± 14.27 | 58.9 ± 12.78 | 58.1 ± 12.44 | 61.3 ± 9.93 | 52.8 ± 24.50 | 58.2 ± 13.24 |
| Sex: Female, Male(Participants) | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 2 | 3 | 14 | 12 | 17 | 3 | 2 | 53 |
| Male | 2 | 1 | 8 | 6 | 6 | 9 | 2 | 34 |
| Race/Ethnicity, Customized(participants) | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | Total |
|---|---|---|---|---|---|---|---|---|
| White/Caucasian | 4 | 3 | 19 | 17 | 23 | 9 | 4 | 79 |
| Asian | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 4 |
| Other | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
| Black/African American | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | PART 1 Dose 1 (7 mg) | PART 1 Dose 2 (20 mg) | PART 1 Dose 3 (70 mg) | PART 1 Dose 4 (200 mg) | PART 1 Dose 5 (350 mg) | PART 1 Dose 6 (700 mg) | PART 1 Dose 7 (1400 mg) | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 4 |
| Not Hispanic or Latino | 4 | 4 | 19 | 16 | 22 | 11 | 2 | 78 |
| Not Reported | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 4 |
| Other | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2016 to primary completion in Mar 2019, 28 months.
Results were first posted in May 2020, 1 year 1 month after primary completion.
Of 127 industry-sponsored phase 1/2 interventional studies under Neoplasm Metastasis, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's 28 months is below that.
Counting every sponsor, half of 213 studies reached it within 62 months; a quarter within 41 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
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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