A Phase 1/2 interventional study of ladiratuzumab vedotin and Pembrolizumab in Triple Negative Breast Neoplasms, sponsored by Seagen Inc.. Completed at 50 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Seagen Inc. (part of Pfizer) · Phase 1/2, Interventional, and Treatment
This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
The primary goal of this study is to evaluate the combination of LV, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action.
This is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's enrollment of 185 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Seagen Inc. is the lead sponsor of 88 studies on the registry; 1 is open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 14 (52%) have results posted.
First submitted before Seagen Inc. became part of Pfizer.
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.
or locally-advanced, documented TNBC (absence of , ER, and PR expression)
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 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.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
LV + pembrolizumab
Drug: ladiratuzumab vedotin · Drug: Pembrolizumab
Given into the vein (IV; intravenously)
Also known as: LV, SGN-LIV1A
IV infusion every 3 weeks
Also known as: KEYTRUDA®
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs were defined as newly occurring (not present at baseline) or worsened after first dose of investigational product within 30 days after last dose date or within 90 days for SAE. AEs included SAEs and all non-SAEs.
Time frame: From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)
Number of Participants With Treatment Related TEAEs and SAEs
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. AEs included SAEs and all non-SAEs. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. Relatedness to study drug was assessed by the investigator.
Time frame: From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months)
Number of Participants With AEs of Grade <3 and Grade >=3 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. AEs severities were graded using the NCI CTCAE v4.03; where Grade 1= mild AE, Grade 2= moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated, Grade 5= indicated death related to AE.
Time frame: From start of study treatment up to 30 days for AEs (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months)
Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any hematology parameter are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Hematology parameters evaluated: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets.
Time frame: Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)
Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any serum chemistry parameters are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Serum chemistry parameters evaluated: alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, calcium- ionized, creatinine, gamma glutamyl transferase, glucose, lipase, phosphate, potassium, sodium and urate. In this outcome measure, only those grades as rows are reported which had at least one participant for at least 1 reporting group.
Time frame: Post-baseline up to 30 days after last dose (maximum exposure to any study intervention was 27 months; follow-up = maximum up to 28 months)
Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C
DLT : hematologic and/or non-hematologic AE specified in protocol that is considered related to SGN-LIV or the combination and cannot be attributed to pembrolizumab alone including: any clinically significant, non-hematologic AE\>= Grade 3 according to NCI CTCAE v4.03, Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant bleeding that required medical intervention, Grade 4 anemia unrelated to underlying disease, discontinuation during Cycle 1 due to treatment-related toxicity/ inability to receive all 3 doses of SGN-LIV (Days 1, 8, and 15) as participant not met dosing criteria (Part C only)prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity and Grade 5 event (death).
Time frame: Cycle 1 (up to 21 days)
ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Kaplan Meier method was used for analysis.
Time frame: From start of study treatment up to date of confirmed CR or PR (maximum up to 30 months)
Duration of Response (DOR) Per RECIST v1.1
DOR = time from first documentation of objective response (subsequently confirmed) per investigator to first documentation of disease progression, or death due to any cause, whichever came first. CR: disappearance of all target lesions. Any pathological lymph nodes (reduction in short axis to \<10 mm). PR: \>=30% decrease in sum of diameters of target lesions, taking reference baseline sum diameters. Progression: at least a 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Kaplan-Meier method used for DOR evaluation. DOR was only calculated for subgroup of participants who achieved a confirmed CR or PR.
Time frame: From the date of first CR or PR until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)
Disease Control Rate (DCR)
DCR was defined as percentage of participants with CR, PR, or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Clopper-Pearson method was used for 95% confidence interval.
Time frame: From start of study treatment up to date of CR or PR or SD (maximum up to 30 months)
Progression-Free Survival (PFS)
PFS was defined as the time from start of study treatment to first documentation of disease progression based upon the disease assessment per RECISTv1.1 or clinical progression, or to death due to any cause, whichever came first. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions. Kaplan-Meier method was used for PFS evaluation.
Time frame: From start of study treatment until the date of the first documentation of progression or death, or censoring date, whichever came first (maximum up to 30 months)
Overall Survival (OS)
OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, OS was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for OS evaluation.
Time frame: From start of study treatment until the date of death, or censoring date, whichever came first (maximum up to 30 months)
A total of 185 participants were enrolled at multiple sites.
| Milestone | Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|---|---|
| Started | 7 | 12 | 26 | 47 | 3 | 53 | 37 |
| Treated | 7 | 12 | 26 | 47 | 3 | 53 | 37 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 7 | 12 | 26 | 47 | 3 | 53 | 37 |
| Withdrew: Withdrawal by subject | 1 | 1 | 1 | 5 | 0 | 4 | 3 |
| Withdrew: Site terminated | 0 | 1 | 1 | 1 | 0 | 2 | 8 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 | 4 | 0 | 4 | 2 |
| Withdrew: Death | 5 | 8 | 18 | 31 | 1 | 29 | 7 |
| Withdrew: Discontinuation per sponsor | 0 | 1 | 2 | 4 | 1 | 9 | 12 |
| Withdrew: Discontinuation per protocol amendment 11 | 0 | 0 | 0 | 1 | 0 | 3 | 5 |
| Withdrew: Treatment landscape | 0 | 0 | 1 | 1 | 0 | 1 | 0 |
| Withdrew: Alanine aminotransferase (alt) increased | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Elevated aspartate aminotransferase (ast) | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Hospice | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Progressive | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. TEAEs were defined as newly occurring (not present at baseline) or worsened after first dose of investigational product within 30 days after last dose date or within 90 days for SAE. AEs included SAEs and all non-SAEs.
| Participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Participants With TEAEs | 32 | 59 | 2 | 53 | 36 |
| Participants With SAEs | 17 | 35 | 1 | 28 | 14 |
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect and other medically significant events. AEs included SAEs and all non-SAEs. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. AEs were defined as treatment emergent if they were newly occurring or worsened following study treatment. Relatedness to study drug was assessed by the investigator.
| Participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Participants With Treatment Related TEAEs | 29 | 58 | 2 | 52 | 35 |
| Participants With Treatment Related SAEs | 6 | 20 | 0 | 20 | 8 |
An AE was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. AEs severities were graded using the NCI CTCAE v4.03; where Grade 1= mild AE, Grade 2= moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated, Grade 5= indicated death related to AE.
| Participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| < Grade 3 | 10 | 10 | 0 | 6 | 5 |
| >= Grade 3 | 22 | 49 | 2 | 47 | 31 |
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any hematology parameter are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Hematology parameters evaluated: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets.
| Participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Grade 0 | 2 | 3 | 0 | 4 | 2 |
| Grade 1 | 6 | 8 | 1 | 6 | 6 |
| Grade 2 | 12 | 27 | 1 | 25 | 12 |
| Grade 3 | 8 | 15 | 0 | 14 | 13 |
| Grade 4 | 1 | 5 | 0 | 4 | 3 |
| Missing | 3 | 1 | 0 | 0 | 0 |
In this outcome measure, number of participants with maximum post-baseline laboratory toxicity grade in any serum chemistry parameters are reported. As per NCI-CTCAE v4.03: Grade 1= mild, Grade 2= moderate, Grade 3= severe, and Grade 4= life-threatening consequences; urgent intervention indicated; Grade 0 = within normal limits. Baseline was defined as most recent non-missing lab result before first dose. Serum chemistry parameters evaluated: alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, calcium- ionized, creatinine, gamma glutamyl transferase, glucose, lipase, phosphate, potassium, sodium and urate. In this outcome measure, only those grades as rows are reported which had at least one participant for at least 1 reporting group.
| Participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Grade 1 | 10 | 9 | 1 | 4 | 12 |
| Grade 2 | 6 | 4 | 1 | 10 | 4 |
| Garde 3 | 12 | 37 | 0 | 36 | 17 |
| Grade 4 | 1 | 9 | 0 | 3 | 3 |
| Missing | 3 | 0 | 0 | 0 | 0 |
DLT : hematologic and/or non-hematologic AE specified in protocol that is considered related to SGN-LIV or the combination and cannot be attributed to pembrolizumab alone including: any clinically significant, non-hematologic AE\>= Grade 3 according to NCI CTCAE v4.03, Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia associated with clinically significant bleeding that required medical intervention, Grade 4 anemia unrelated to underlying disease, discontinuation during Cycle 1 due to treatment-related toxicity/ inability to receive all 3 doses of SGN-LIV (Days 1, 8, and 15) as participant not met dosing criteria (Part C only)prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity and Grade 5 event (death).
| Participants | Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab |
|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C | 0 | 2 | 0 | 0 |
ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Kaplan Meier method was used for analysis.
| Percentage of participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 | 34 (18.6 to 53.2) | 41 (28.1 to 54.3) | 50 (1.3 to 98.7) | 47 (33.3 to 61.4) | 39 (23.1 to 56.5) |
DOR = time from first documentation of objective response (subsequently confirmed) per investigator to first documentation of disease progression, or death due to any cause, whichever came first. CR: disappearance of all target lesions. Any pathological lymph nodes (reduction in short axis to \<10 mm). PR: \>=30% decrease in sum of diameters of target lesions, taking reference baseline sum diameters. Progression: at least a 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Kaplan-Meier method used for DOR evaluation. DOR was only calculated for subgroup of participants who achieved a confirmed CR or PR.
| Months | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Duration of Response (DOR) Per RECIST v1.1 | 4.5 (2.9 to 6.9) | 5.8 (3.1 to 9.9) | 4.2 (NA to NA) | 4.4 (3.6 to 6.6) | 8.3 (5.7 to NA) |
DCR was defined as percentage of participants with CR, PR, or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions. Clopper-Pearson method was used for 95% confidence interval.
| Percentage of participants | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Disease Control Rate (DCR) | 59 (40.6 to 76.3) | 81 (69.1 to 90.3) | 50 (1.3 to 98.7) | 77 (63.8 to 87.7) | 69 (51.9 to 83.7) |
PFS was defined as the time from start of study treatment to first documentation of disease progression based upon the disease assessment per RECISTv1.1 or clinical progression, or to death due to any cause, whichever came first. Progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions. Kaplan-Meier method was used for PFS evaluation.
| Months | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | 3.5 (1.7 to 4.1) | 4.2 (3.9 to 5.6) | 3.3 (1.0 to NA) | 4.8 (4.1 to 5.6) | 4.2 (2.7 to 8.3) |
OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, OS was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for OS evaluation.
| Months | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|
| Overall Survival (OS) | 14.6 (8.1 to 26.6) | 14.8 (11.9 to 25.9) | NA (NA to NA) | 19.4 (11.1 to NA) | NA (NA to NA) |
Collected over From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; All-cause mortality, SAEs = maximum up to 30 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | 5/7 (71.4%) | 4/7 (57.1%) | 7/7 (100%) |
| Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | 8/12 (66.7%) | 8/12 (66.7%) | 12/12 (100%) |
| Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | 18/26 (69.2%) | 13/26 (50%) | 23/26 (88.5%) |
| Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | 31/47 (66%) | 27/47 (57.4%) | 47/47 (100%) |
| Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | 1/3 (33.3%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | 29/53 (54.7%) | 28/53 (52.8%) | 53/53 (100%) |
| Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab | 7/37 (18.9%) | 14/37 (37.8%) | 36/37 (97.3%) |
| Event | Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/7 | 1/12 | 0/26 | 0/47 | 1/3 | 2/53 | 0/37 |
| Abdominal painGastrointestinal disorders | 1/7 | 2/12 | 1/26 | 0/47 | 0/3 | 2/53 | 0/37 |
| IleusGastrointestinal disorders | 0/7 | 2/12 | 0/26 | 0/47 | 0/3 | 0/53 | 0/37 |
| HeadacheNervous system disorders | 0/7 | 2/12 | 2/26 | 1/47 | 0/3 | 0/53 | 0/37 |
| AnaemiaBlood and lymphatic system disorders | 1/7 | 0/12 | 0/26 | 0/47 | 0/3 | 2/53 | 0/37 |
| Sinus tachycardiaCardiac disorders | 1/7 | 0/12 | 0/26 | 1/47 | 0/3 | 0/53 | 0/37 |
| ConstipationGastrointestinal disorders | 1/7 | 1/12 | 0/26 | 1/47 | 0/3 | 0/53 | 0/37 |
| Small intestinal obstructionGastrointestinal disorders | 1/7 | 0/12 | 0/26 | 1/47 | 0/3 | 0/53 | 0/37 |
| CellulitisInfections and infestations | 1/7 | 0/12 | 1/26 | 0/47 | 0/3 | 0/53 | 0/37 |
| Urinary tract infectionInfections and infestations | 1/7 | 0/12 | 0/26 | 1/47 | 0/3 | 2/53 | 0/37 |
| Event | Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab |
|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 7/7 | 9/12 | 12/26 | 32/47 | 0/3 | 35/53 | 20/37 |
| FatigueGeneral disorders | 5/7 | 10/12 | 11/26 | 31/47 | 1/3 | 32/53 | 16/37 |
| DiarrhoeaGastrointestinal disorders | 4/7 | 9/12 | 5/26 | 26/47 | 0/3 | 30/53 | 16/37 |
| AlopeciaSkin and subcutaneous tissue disorders | 5/7 | 7/12 | 7/26 | 25/47 | 1/3 | 17/53 | 12/37 |
| Sinus tachycardiaCardiac disorders | 0/7 | 0/12 | 0/26 | 0/47 | 2/3 | 0/53 | 0/37 |
| VomitingGastrointestinal disorders | 1/7 | 7/12 | 4/26 | 14/47 | 0/3 | 17/53 | 13/37 |
| Decreased appetiteMetabolism and nutrition disorders | 2/7 | 7/12 | 9/26 | 18/47 | 0/3 | 19/53 | 10/37 |
| HypokalaemiaMetabolism and nutrition disorders | 3/7 | 7/12 | 4/26 | 11/47 | 0/3 | 15/53 | 9/37 |
| Weight decreasedInvestigations | 2/7 | 6/12 | 5/26 | 13/47 | 1/3 | 19/53 | 11/37 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/7 | 6/12 | 8/26 | 13/47 | 0/3 | 14/53 | 12/37 |
As pre-specified in the statistical analysis plan (SAP), data was summarized by dose levels. Since Arm A and Arm B share the same dose levels (2.0 mg/kg and 2.5 mg/kg), these dose levels were combined across both arms.
| Age, Continuous(Years) | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab | Total |
|---|---|---|---|---|---|---|
| Mean | 53.4 ± 12.1 | 55.2 ± 12.7 | 45.0 ± 14.1 | 57.6 ± 12.7 | 54.6 ± 11.0 | 55.4 ± 12.3 |
| Sex: Female, Male(Participants) | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab | Total |
|---|---|---|---|---|---|---|
| Female | 33 | 59 | 3 | 53 | 37 | 185 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 7 | 0 | 5 | 4 | 20 |
| Not Hispanic or Latino | 29 | 45 | 2 | 43 | 29 | 148 |
| Unknown or Not Reported | 0 | 7 | 1 | 5 | 4 | 17 |
| Race/Ethnicity, Customized(Participants) | Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab | Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab | Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab | Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab | Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab | Total |
|---|---|---|---|---|---|---|
| White | 19 | 44 | 0 | 31 | 33 | 127 |
| Black or African American | 9 | 8 | 1 | 10 | 3 | 31 |
| Asian | 4 | 1 | 1 | 6 | 1 | 13 |
| American Indian or Alaska Native | 0 | 1 | 0 | 2 | 0 | 3 |
| Unknown | 0 | 5 | 1 | 4 | 0 | 10 |
| Other | 1 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Sep 2024, 79 months.
Results were first posted in Dec 2025, 1 year 2 months after primary completion.
Of 70 industry-sponsored phase 1/2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 77. This study's 79 months is above that.
Counting every sponsor, half of 118 studies reached it within 56 months; a quarter within 43 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SGN-LIV1A
Triple Negative Breast Neoplasms →