NCT04032704 is a Phase 2 clinical trial of ladiratuzumab vedotin in Small Cell Lung Cancer, sponsored by Seagen Inc..

Who is sponsoring NCT04032704?

NCT04032704 is sponsored by Seagen Inc..

What drugs are being tested in NCT04032704?

Interventions in NCT04032704: ladiratuzumab vedotin, pembrolizumab.

What condition does NCT04032704 study?

NCT04032704 studies Small Cell Lung Cancer, Non-small Cell Lung Cancer, Squamous, Non-small Cell Lung Cancer, Non-squamous, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Prostate Cancer, Melanoma.

Is NCT04032704 still recruiting?

NCT04032704 is currently terminated. Last updated 10 March 2025.

Are results published for NCT04032704?

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

Last reviewed 2025-03-10 · How we verify

NCT04032704

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

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Terminated Phase 2 Results posted Last updated 10 March 2025

What this trial tests

Phase 2 trial testing ladiratuzumab vedotin in Small Cell Lung Cancer in 205 participants. Terminated before completion.

Timeline

9 October 2019

Primary endpoint
28 November 2023

28 November 2023

Quick facts

Lead sponsor	Seagen Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	205
Start date	9 October 2019
Primary completion	28 November 2023
Estimated completion	28 November 2023
Sites	66 locations across Italy, Taiwan, United Kingdom, South Korea, Australia, United States

Drugs / interventions tested

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

Conditions studied

Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →
Non-small Cell Lung Cancer, Squamous — all drugs for Non-small Cell Lung Cancer, Squamous →
Non-small Cell Lung Cancer, Non-squamous — all drugs for Non-small Cell Lung Cancer, Non-squamous →
Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

Seagen Inc. — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Cancer or Non-small Cell Lung Cancer, Squamous. 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.

Part A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Primary · From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months)

Confirmed ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as more than or equal to (\>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-resp

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	10	0.3 – 44.5
Part A: Cohort 2, LV 2.5 mg/kg	0	0.0 – 84.2
Part A: Cohort 3, LV 2.5 mg/kg	8	0.2 – 36.0
Part A: Cohort 4, LV 2.5 mg/kg	14	0.4 – 57.9
Part A: Cohort 5, LV 2.5 mg/kg	20	0.5 – 71.6
Part A: Cohort 6, LV 2.5 mg/kg	8	0.2 – 38.5

Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1 Primary · From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

Confirmed ORR was defined as the percentage of participants with a confirmed CR or PR per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as \>= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	6	0.2 – 30.2
Part B: Cohort 2, LV 1.25 mg/kg	13	1.6 – 38.3
Part B: Cohort 3, LV 1.25 mg/kg	11	1.3 – 33.1
Part B: Cohort 4, LV 1.25 mg/kg	0	0.0 – 23.2
Part B: Cohort 5, LV 1.25 mg/kg	18	3.8 – 43.4
Part B: Cohort 6, LV 1.25 mg/kg	14	3.0 – 36.3
Part B: Cohort 7, LV 1.25 mg/kg	0	0.0 – 24.7
Part B: Cohort 8, LV 1.25 mg/kg	20	7.7 – 38.6
Part B: Cohort 1, LV 1.0 mg/kg	0	0.0 – 84.2
Part B: Cohort 3, LV 1.0 mg/kg	0	0.0 – 84.2
Part B: Cohort 4, LV 1.0 mg/kg	0	0.0 – 84.2
Part B: Cohort 6, LV 1.0 mg/kg	50	1.3 – 98.7

Part B: Confirmed Prostate-Specific Antigen (PSA) Response Rate as Determined by Investigator According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria, for Prostate Cancer Primary · From the first dose of study treatment up to the date of last response assessment (maximum up to 13.5 months)

Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice \>= 3 weeks apart. PSA progression was defined as per PCWG3 criteria- a) if a participant presented first a decline from baseline, progression was defined as the first PSA increase that was \>=25% and \>=2 nanograms per milliliter (ng/mL) above the nadir, and which was confirmed by a consecutive second value \>=3 weeks later that fulfilled the same criteria (that is, a confirmed rising trend); b) if a participant did not present a decline from basel

Group	Value	95% CI
Part B: Cohort 7, LV 1.25 mg/kg	23	5.0 – 53.8

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE Secondary · From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)

An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. T

TEAEs

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	10
Part A: Cohort 2, LV 2.5 mg/kg	2
Part A: Cohort 3, LV 2.5 mg/kg	13
Part A: Cohort 4, LV 2.5 mg/kg	7
Part A: Cohort 5, LV 2.5 mg/kg	5
Part A: Cohort 6, LV 2.5 mg/kg	12

TESAEs

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	5
Part A: Cohort 2, LV 2.5 mg/kg	1
Part A: Cohort 3, LV 2.5 mg/kg	7
Part A: Cohort 4, LV 2.5 mg/kg	2
Part A: Cohort 5, LV 2.5 mg/kg	3
Part A: Cohort 6, LV 2.5 mg/kg	3

Treatment Related TEAEs

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	9
Part A: Cohort 2, LV 2.5 mg/kg	2
Part A: Cohort 3, LV 2.5 mg/kg	11
Part A: Cohort 4, LV 2.5 mg/kg	7
Part A: Cohort 5, LV 2.5 mg/kg	5
Part A: Cohort 6, LV 2.5 mg/kg	11

TEAEs (>= Grade 3)

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	7
Part A: Cohort 2, LV 2.5 mg/kg	1
Part A: Cohort 3, LV 2.5 mg/kg	9
Part A: Cohort 4, LV 2.5 mg/kg	4
Part A: Cohort 5, LV 2.5 mg/kg	4
Part A: Cohort 6, LV 2.5 mg/kg	6

Part B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAE Secondary · From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)

An AE was any untoward medical occurrence in a participant, or a clinical investigational participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline) or worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent or significant disability or incapacity and may cause congenital anomaly or birth defect

TEAEs

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	15
Part B: Cohort 2, LV 1.25 mg/kg	16
Part B: Cohort 3, LV 1.25 mg/kg	19
Part B: Cohort 4, LV 1.25 mg/kg	14
Part B: Cohort 5, LV 1.25 mg/kg	17
Part B: Cohort 6, LV 1.25 mg/kg	21
Part B: Cohort 7, LV 1.25 mg/kg	13
Part B: Cohort 8, LV 1.25 mg/kg	30
Part B: Cohort 1, LV 1.0 mg/kg	2
Part B: Cohort 3, LV 1.0 mg/kg	2
Part B: Cohort 4, LV 1.0 mg/kg	2
Part B: Cohort 6, LV 1.0 mg/kg	2

TESAEs

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	6
Part B: Cohort 2, LV 1.25 mg/kg	5
Part B: Cohort 3, LV 1.25 mg/kg	9
Part B: Cohort 4, LV 1.25 mg/kg	8
Part B: Cohort 5, LV 1.25 mg/kg	9
Part B: Cohort 6, LV 1.25 mg/kg	12
Part B: Cohort 7, LV 1.25 mg/kg	4
Part B: Cohort 8, LV 1.25 mg/kg	11
Part B: Cohort 1, LV 1.0 mg/kg	1
Part B: Cohort 3, LV 1.0 mg/kg	2
Part B: Cohort 4, LV 1.0 mg/kg	1
Part B: Cohort 6, LV 1.0 mg/kg	0

Treatment Related TEAEs

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	13
Part B: Cohort 2, LV 1.25 mg/kg	16
Part B: Cohort 3, LV 1.25 mg/kg	18
Part B: Cohort 4, LV 1.25 mg/kg	12
Part B: Cohort 5, LV 1.25 mg/kg	17
Part B: Cohort 6, LV 1.25 mg/kg	19
Part B: Cohort 7, LV 1.25 mg/kg	12
Part B: Cohort 8, LV 1.25 mg/kg	28
Part B: Cohort 1, LV 1.0 mg/kg	2
Part B: Cohort 3, LV 1.0 mg/kg	2
Part B: Cohort 4, LV 1.0 mg/kg	2
Part B: Cohort 6, LV 1.0 mg/kg	2

TEAEs (>= Grade 3)

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	12
Part B: Cohort 2, LV 1.25 mg/kg	11
Part B: Cohort 3, LV 1.25 mg/kg	14
Part B: Cohort 4, LV 1.25 mg/kg	11
Part B: Cohort 5, LV 1.25 mg/kg	13
Part B: Cohort 6, LV 1.25 mg/kg	17
Part B: Cohort 7, LV 1.25 mg/kg	8
Part B: Cohort 8, LV 1.25 mg/kg	17
Part B: Cohort 1, LV 1.0 mg/kg	1
Part B: Cohort 3, LV 1.0 mg/kg	2
Part B: Cohort 4, LV 1.0 mg/kg	1
Part B: Cohort 6, LV 1.0 mg/kg	0

Part A: Confirmed Investigator Determined Disease Control Rate (DCR) According to RECIST v1.1 Secondary · From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 4.1 months)

DCR was defined as percentage of participants who achieved confirmed and unconfirmed CR or PR per RECIST v1.1 or met stable disease (SD) criteria at least once after start of study treatment at minimum interval of 5 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as \>= 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as ref

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	40	12.2 – 73.8
Part A: Cohort 2, LV 2.5 mg/kg	50	1.3 – 98.7
Part A: Cohort 3, LV 2.5 mg/kg	46	19.2 – 74.9
Part A: Cohort 4, LV 2.5 mg/kg	57	18.4 – 90.1
Part A: Cohort 5, LV 2.5 mg/kg	60	14.7 – 94.7
Part A: Cohort 6, LV 2.5 mg/kg	33	9.9 – 65.1

Part B: Confirmed Investigator Determined DCR According to RECIST v1.1 Secondary · From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 5.5 months for 1.25 mg/kg and 1.5 months for 1 mg/kg dose level)

DCR was defined as percentage of participants who achieved confirmed and unconfirmed CR or PR per RECIST v1.1 or met SD criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as \>= 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 PD, taking as reference the smallest sum diam

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	19	4.0 – 45.6
Part B: Cohort 2, LV 1.25 mg/kg	50	24.7 – 75.3
Part B: Cohort 3, LV 1.25 mg/kg	58	33.5 – 79.7
Part B: Cohort 4, LV 1.25 mg/kg	64	35.1 – 87.2
Part B: Cohort 5, LV 1.25 mg/kg	59	32.9 – 81.6
Part B: Cohort 6, LV 1.25 mg/kg	52	29.8 – 74.3
Part B: Cohort 7, LV 1.25 mg/kg	62	31.6 – 86.1
Part B: Cohort 8, LV 1.25 mg/kg	77	57.7 – 90.1
Part B: Cohort 1, LV 1.0 mg/kg	50	1.3 – 98.7
Part B: Cohort 3, LV 1.0 mg/kg	50	1.3 – 98.7
Part B: Cohort 4, LV 1.0 mg/kg	0	0.0 – 84.2
Part B: Cohort 6, LV 1.0 mg/kg	100	15.8 – 100.0

Part A: Confirmed Investigator Determined Duration of Response (DOR) According to RECIST v1.1 Secondary · From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 5.7 months)

DOR:time from 1st documentation of OR(confirmed CR/PR per RECIST Version 1.1) to 1st documentation of PD/death due to any cause,whichever occurred first.CR:disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to \<10 mm.PR:\>=30 % decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants do not have PD and are still on study at time of analysis/are removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	5.7	NA – NA
Part A: Cohort 3, LV 2.5 mg/kg	5.5	NA – NA
Part A: Cohort 4, LV 2.5 mg/kg	3.7	NA – NA
Part A: Cohort 5, LV 2.5 mg/kg	2.7	NA – NA
Part A: Cohort 6, LV 2.5 mg/kg	NA	NA – NA

Part B: Confirmed Investigator Determined DOR According to RECIST v1.1 Secondary · From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 32.0 months for 1.25 mg/kg and 4.2 months for 1 mg/kg dose level)

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	NA	NA – NA
Part B: Cohort 2, LV 1.25 mg/kg	7.5	5.78 – NA
Part B: Cohort 3, LV 1.25 mg/kg	NA	16.59 – NA
Part B: Cohort 5, LV 1.25 mg/kg	NA	3.06 – NA
Part B: Cohort 6, LV 1.25 mg/kg	3.9	2.60 – NA
Part B: Cohort 8, LV 1.25 mg/kg	8.3	5.62 – NA
Part B: Cohort 6, LV 1.0 mg/kg	4.2	NA – NA

Part B: Confirmed Investigator Determined PSA-DOR, for Prostate Cancer Secondary · From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 3 months)

PSA-DOR was defined as the time from the first documentation of PSA response (subsequently confirmed at least 3 weeks apart) to the first documentation of PSA progression or death due to any cause, whichever occurred first. Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice \>= 3 weeks apart. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD was censored at the date of last disease assessment documenting a

Group	Value	95% CI
Part B: Cohort 7, LV 1.25 mg/kg	3.0	1.9 – NA

Part A: Confirmed Investigator Determined Progression Free Survival (PFS) According to RECIST v1.1 Secondary · From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 8.3 months)

PFS: time from start of study treatment to the first documentation of PD by RECIST v1.1 or clinical PD. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smalles

Group	Value	95% CI
Part A: Cohort 1, LV 2.5 mg/kg	1.4	0.53 – 2.69
Part A: Cohort 2, LV 2.5 mg/kg	1.5	1.25 – NA
Part A: Cohort 3, LV 2.5 mg/kg	2.5	0.46 – 4.17
Part A: Cohort 4, LV 2.5 mg/kg	2.3	0.33 – 4.86
Part A: Cohort 5, LV 2.5 mg/kg	2.9	0.59 – NA
Part A: Cohort 6, LV 2.5 mg/kg	1.4	1.31 – 4.17

Part B: Confirmed Investigator Determined PFS According to RECIST v1.1 Secondary · From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

Group	Value	95% CI
Part B: Cohort 1, LV 1.25 mg/kg	1.4	1.18 – 2.04
Part B: Cohort 2, LV 1.25 mg/kg	1.8	1.12 – 5.72
Part B: Cohort 3, LV 1.25 mg/kg	2.4	1.31 – 2.96
Part B: Cohort 4, LV 1.25 mg/kg	2.7	1.18 – 2.86
Part B: Cohort 5, LV 1.25 mg/kg	2.8	1.38 – 3.32
Part B: Cohort 6, LV 1.25 mg/kg	2.3	1.25 – 2.73
Part B: Cohort 7, LV 1.25 mg/kg	4.9	2.10 – 5.65
Part B: Cohort 8, LV 1.25 mg/kg	4.2	2.50 – 6.97
Part B: Cohort 1, LV 1.0 mg/kg	1.9	1.02 – NA
Part B: Cohort 3, LV 1.0 mg/kg	NA	NA – NA
Part B: Cohort 4, LV 1.0 mg/kg	1.5	1.35 – NA
Part B: Cohort 6, LV 1.0 mg/kg	4.2	2.76 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Cohort 1, LV 2.5 mg/kg

Serious: 5/10 (50%)

Deaths: 9/10

Part A: Cohort 2, LV 2.5 mg/kg

Serious: 1/2 (50%)

Deaths: 2/2

Part A: Cohort 3, LV 2.5 mg/kg

Serious: 7/13 (54%)

Deaths: 10/13

Part A: Cohort 4, LV 2.5 mg/kg

Serious: 2/7 (29%)

Deaths: 7/7

Part A: Cohort 5, LV 2.5 mg/kg

Serious: 3/5 (60%)

Deaths: 4/5

Part A: Cohort 6, LV 2.5 mg/kg

Serious: 3/12 (25%)

Deaths: 5/12

Part B: Cohort 1, LV 1.25 mg/kg

Serious: 6/16 (38%)

Deaths: 13/16

Part B: Cohort 2, LV 1.25 mg/kg

Serious: 5/16 (31%)

Deaths: 13/16

Part B: Cohort 3, LV 1.25 mg/kg

Serious: 9/19 (47%)

Deaths: 14/19

Part B: Cohort 4, LV 1.25 mg/kg

Serious: 8/14 (57%)

Deaths: 12/14

Part B: Cohort 5, LV 1.25 mg/kg

Serious: 9/17 (53%)

Deaths: 12/17

Part B: Cohort 6, LV 1.25 mg/kg

Serious: 12/21 (57%)

Deaths: 13/21

Part B: Cohort 7, LV 1.25 mg/kg

Serious: 4/13 (31%)

Deaths: 7/13

Part B: Cohort 8, LV 1.25 mg/kg

Serious: 11/30 (37%)

Deaths: 16/30

Part B: Cohort 1, LV 1.0 mg/kg

Serious: 1/2 (50%)

Deaths: 2/2

Part B: Cohort 3, LV 1.0 mg/kg

Serious: 2/2 (100%)

Deaths: 1/2

Part B: Cohort 4, LV 1.0 mg/kg

Serious: 1/2 (50%)

Deaths: 2/2

Part B: Cohort 6, LV 1.0 mg/kg

Serious: 0/2 (0%)

Deaths: 2/2

Serious adverse events (101 terms)

Reaction	System	Part A: Cohort 1, LV 2.5 m…	Part A: Cohort 2, LV 2.5 m…	Part A: Cohort 3, LV 2.5 m…	Part A: Cohort 4, LV 2.5 m…	Part A: Cohort 5, LV 2.5 m…	Part A: Cohort 6, LV 2.5 m…	Part B: Cohort 1, LV 1.25 …	Part B: Cohort 2, LV 1.25 …	Part B: Cohort 3, LV 1.25 …	Part B: Cohort 4, LV 1.25 …	Part B: Cohort 5, LV 1.25 …	Part B: Cohort 6, LV 1.25 …	Part B: Cohort 7, LV 1.25 …	Part B: Cohort 8, LV 1.25 …	Part B: Cohort 1, LV 1.0 m…	Part B: Cohort 3, LV 1.0 m…	Part B: Cohort 4, LV 1.0 m…	Part B: Cohort 6, LV 1.0 m…
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pericardial effusion	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stress cardiomyopathy	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Laryngocele	Congenital, familial and genetic disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Adrenal insufficiency	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Inappropriate antidiuretic hormone secretion	Endocrine disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (231 terms — click to expand)

Reaction	System	Part A: Cohort 1, LV 2.5 m…	Part A: Cohort 2, LV 2.5 m…	Part A: Cohort 3, LV 2.5 m…	Part A: Cohort 4, LV 2.5 m…	Part A: Cohort 5, LV 2.5 m…	Part A: Cohort 6, LV 2.5 m…	Part B: Cohort 1, LV 1.25 …	Part B: Cohort 2, LV 1.25 …	Part B: Cohort 3, LV 1.25 …	Part B: Cohort 4, LV 1.25 …	Part B: Cohort 5, LV 1.25 …	Part B: Cohort 6, LV 1.25 …	Part B: Cohort 7, LV 1.25 …	Part B: Cohort 8, LV 1.25 …	Part B: Cohort 1, LV 1.0 m…	Part B: Cohort 3, LV 1.0 m…	Part B: Cohort 4, LV 1.0 m…	Part B: Cohort 6, LV 1.0 m…
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Asthenia, Cardiac arrest, Constipation, Pneumonia, Dehydration, Hyponatraemia, Myalgia.

Data from ClinicalTrials.gov NCT04032704 adverse events section.

Sponsor's own description

This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.

Publications & conference data

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

Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
Cellular zinc metabolism and zinc signaling: from biological functions to diseases and therapeutic targets.
Chen B, Yu P, Chan WN, Xie F, et al · · 2024 · cited 195× · PMID 38169461 · DOI 10.1038/s41392-023-01679-y
Antibody-drug conjugates in solid tumors: a look into novel targets.
Criscitiello C, Morganti S, Curigliano G. · · 2021 · cited 169× · PMID 33509252 · DOI 10.1186/s13045-021-01035-z
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
Recent advances of antibody drug conjugates for clinical applications.
Zhao P, Zhang Y, Li W, Jeanty C, et al · · 2020 · cited 122× · PMID 33088681 · DOI 10.1016/j.apsb.2020.04.012
Marine Natural Products in Clinical Use.
Haque N, Parveen S, Tang T, Wei J, et al · · 2022 · cited 101× · PMID 36005531 · DOI 10.3390/md20080528
Biomarkers in Triple-Negative Breast Cancer: State-of-the-Art and Future Perspectives.
Cocco S, Piezzo M, Calabrese A, Cianniello D, et al · · 2020 · cited 91× · PMID 32605126 · DOI 10.3390/ijms21134579
Biomaterials from the sea: Future building blocks for biomedical applications.
Wan MC, Qin W, Lei C, Li QH, et al · · 2021 · cited 69× · PMID 33997505 · DOI 10.1016/j.bioactmat.2021.04.028

Verify or expand the search:

Other trials of ladiratuzumab vedotin

Trials testing the same drug.

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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

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Currently open trials in the same condition.

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Other Seagen Inc. trials

Trials by the same sponsor.

NCT05244473 — A Safety Study of Brentuximab Vedotin in Participants With HIV · Phase 1 · withdrawn
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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 NCT04032704 (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: 10 March 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/NCT04032704.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04032704

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (101 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of ladiratuzumab vedotin

Other recruiting trials for Small Cell Lung Cancer

Other Seagen Inc. trials

Verify against primary sources