NCT03310957 is a Phase 1, PHASE2 clinical trial of ladiratuzumab vedotin in Triple Negative Breast Neoplasms, sponsored by Seagen Inc..

Who is sponsoring NCT03310957?

NCT03310957 is sponsored by Seagen Inc..

What drugs are being tested in NCT03310957?

Interventions in NCT03310957: ladiratuzumab vedotin, Pembrolizumab.

What condition does NCT03310957 study?

NCT03310957 studies Triple Negative Breast Neoplasms.

Is NCT03310957 still recruiting?

NCT03310957 is currently completed. Last updated 12 December 2025.

Are results published for NCT03310957?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-12-12 · How we verify

NCT03310957

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

Completed Phase 1, PHASE2 Results posted Last updated 12 December 2025

What this trial tests

Phase 1, PHASE2 trial testing ladiratuzumab vedotin in Triple Negative Breast Neoplasms in 185 participants. Completed in 30 September 2024.

Timeline

27 February 2018

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	Seagen Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	185
Start date	27 February 2018
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	50 locations across United States, Germany, Spain, South Korea

Drugs / interventions tested

ladiratuzumab vedotin — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Triple Negative Breast Neoplasms — all drugs for Triple Negative Breast Neoplasms →

Sponsor

Seagen Inc. — full company profile →

Who can join

18 and older, any sex, with Triple Negative Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · 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)

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 ba

Participants With TEAEs

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	32
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	59
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	2
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	53
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	36

Participants With SAEs

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	17
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	35
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	1
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	28
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	14

Number of Participants With Treatment Related TEAEs and SAEs Primary · 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)

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 untow

Participants With Treatment Related TEAEs

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	29
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	58
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	2
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	52
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	35

Participants With Treatment Related SAEs

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	6
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	20
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	20
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	8

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 Primary · 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)

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.

< Grade 3

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	10
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	10
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	6
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	5

>= Grade 3

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	22
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	49
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	2
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	47
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	31

Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter Primary · 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)

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.

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	2
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	3
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	4
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	2
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	6
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	8
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	1
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	6
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	6
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	12
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	27
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	1
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	25
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	12
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	8
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	15
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	14
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	13

Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter Primary · 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)

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,

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	10
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	9
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	1
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	4
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	12
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	6
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	4
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	1
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	10
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	4
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	12
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	37
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	36
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	17
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	1
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	9
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	3
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	3

Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C Primary · Cycle 1 (up to 21 days)

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

Group	Value	95% CI
Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	0
Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	2
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	0
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	0

ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Primary · From start of study treatment up to date of confirmed CR or PR (maximum up to 30 months)

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.

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	34	18.6 – 53.2
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	41	28.1 – 54.3
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	50	1.3 – 98.7
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	47	33.3 – 61.4
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	39	23.1 – 56.5

Duration of Response (DOR) Per RECIST v1.1 Secondary · 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)

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 o

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	4.5	2.9 – 6.9
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	5.8	3.1 – 9.9
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	4.2	NA – NA
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	4.4	3.6 – 6.6
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	8.3	5.7 – NA

Disease Control Rate (DCR) Secondary · From start of study treatment up to date of CR or PR or SD (maximum up to 30 months)

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

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	59	40.6 – 76.3
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	81	69.1 – 90.3
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	50	1.3 – 98.7
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	77	63.8 – 87.7
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	69	51.9 – 83.7

Progression-Free Survival (PFS) Secondary · 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)

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 metho

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	3.5	1.7 – 4.1
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	4.2	3.9 – 5.6
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	3.3	1.0 – NA
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	4.8	4.1 – 5.6
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	4.2	2.7 – 8.3

Overall Survival (OS) Secondary · From start of study treatment until the date of death, or censoring date, whichever came first (maximum up to 30 months)

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.

Group	Value	95% CI
Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab	14.6	8.1 – 26.6
Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab	14.8	11.9 – 25.9
Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab	NA	NA – NA
Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab	19.4	11.1 – NA
Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

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; All-cause mortality, SAEs = maximum up to 30 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab

Serious: 4/7 (57%)

Deaths: 5/7

Part A: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab

Serious: 8/12 (67%)

Deaths: 8/12

Part B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab

Serious: 13/26 (50%)

Deaths: 18/26

Part B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab

Serious: 27/47 (57%)

Deaths: 31/47

Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab

Serious: 1/3 (33%)

Deaths: 1/3

Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab

Serious: 28/53 (53%)

Deaths: 29/53

Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab

Serious: 14/37 (38%)

Deaths: 7/37

Serious adverse events (121 terms)

Reaction	System	Part A: SGN-LIV 2.0 mg/kg …	Part A: SGN-LIV 2.5 mg/kg …	Part B: SGN-LIV 2.0 mg/kg …	Part B: SGN-LIV 2.5 mg/kg …	Part C: SGN-LIV 1.0 mg/kg …	Part C: SGN-LIV 1.25 mg/kg…	Part D: SGN-LIV 1.5 mg/kg …
Sepsis	Infections and infestations	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Peripheral motor neuropathy	Nervous system disorders	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—	—	—	—	—

Other adverse events (186 terms — click to expand)

Reaction	System	Part A: SGN-LIV 2.0 mg/kg …	Part A: SGN-LIV 2.5 mg/kg …	Part B: SGN-LIV 2.0 mg/kg …	Part B: SGN-LIV 2.5 mg/kg …	Part C: SGN-LIV 1.0 mg/kg …	Part C: SGN-LIV 1.25 mg/kg…	Part D: SGN-LIV 1.5 mg/kg …
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Hypertransaminasaemia	Hepatobiliary disorders	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Peripheral motor neuropathy	Nervous system disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Sepsis, Diarrhoea, Acute kidney injury, Anaemia, Febrile neutropenia, Abdominal pain, Colitis, Ileus.

Data from ClinicalTrials.gov NCT03310957 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in therapeutic strategies for triple-negative breast cancer.
Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
Triple negative breast cancer: Pitfalls and progress.
Zagami P, Carey LA. · · 2022 · cited 546× · PMID 35987766 · DOI 10.1038/s41523-022-00468-0
Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
Triple‑negative breast cancer therapy: Current and future perspectives (Review).
Won KA, Spruck C. · · 2020 · cited 351× · PMID 33174058 · DOI 10.3892/ijo.2020.5135
Breast Cancer Treatments: Updates and New Challenges.
Burguin A, Diorio C, Durocher F. · · 2021 · cited 297× · PMID 34442452 · DOI 10.3390/jpm11080808
Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
Recent advances in targeted strategies for triple-negative breast cancer.
Zhu S, Wu Y, Song B, Yi M, et al · · 2023 · cited 200× · PMID 37641116 · DOI 10.1186/s13045-023-01497-3
Advances in immunotherapy for triple-negative breast cancer.
Liu Y, Hu Y, Xue J, Li J, et al · · 2023 · cited 198× · PMID 37660039 · DOI 10.1186/s12943-023-01850-7

Verify or expand the search:

Other trials of ladiratuzumab vedotin

Trials testing the same drug.

NCT04032704 — A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors · Phase 2 · terminated
NCT01969643 — A Safety Study of SGN-LIV1A in Breast Cancer Patients · Phase 1 · completed
NCT06362590 — Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors · available

Other recruiting trials for Triple Negative Breast Neoplasms

Currently open trials in the same condition.

NCT06966700 — A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) · Phase 3 · recruiting
NCT06841354 — A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in · Phase 3 · recruiting
NCT05485766 — Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer · Phase 2 · recruiting
NCT06157892 — A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors · Phase 2 · recruiting
NCT06385990 — Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy · Phase 2 · recruiting

Other Seagen Inc. trials

Trials by the same sponsor.

NCT05244473 — A Safety Study of Brentuximab Vedotin in Participants With HIV · Phase 1 · withdrawn
NCT05229900 — A Study of SGN-ALPV in Advanced Solid Tumors · Phase 1 · terminated
NCT04993677 — A Study of SEA-CD40 Given With Other Drugs in Cancers · Phase 2 · completed
NCT04499924 — Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastro · Phase 2, PHASE3 · completed
NCT04665921 — A Study of SGN-STNV in Advanced Solid Tumors · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03310957 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seagen Inc.
Last refreshed: 12 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03310957.

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