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Trial ยท NCT04032704

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

NCT04032704, Phase 2, Terminated, Seagen Inc.; results first posted 2025-03-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors. Trials, record NCT04032704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04032704

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
NCT number
NCT04032704
Status
Terminated
Phases
Phase 2
Enrollment
205 participants, actual
Lead sponsor
Seagen Inc.
Conditions
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
Interventions
ladiratuzumab vedotin, pembrolizumab
First posted
2019-07-25
Last updated
2025-03-10
Results first posted
2025-03-10

Source ClinicalTrials.gov

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPart A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)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-responders.
PrimaryPart B: Confirmed ORR as Determined by Investigator According to RECIST v1.1
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.
PrimaryPart 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 CancerFrom 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 baseline, progression was defined as the first PSA increase that was \>=25% and \>=2 ng/mL increased from baseline beyond 12 weeks.
SecondaryPart A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAEFrom 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. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
SecondaryPart B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAEFrom 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. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI-CTCAE v4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
SecondaryPart A: Confirmed Investigator Determined Disease Control Rate (DCR) According to RECIST v1.1From 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 reference smallest sum diameters while on study. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included 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 was also considered progression.
SecondaryPart B: Confirmed Investigator Determined DCR According to RECIST v1.1
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 diameters while on study. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included 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 centimeter (cm). Appearance of one or more new lesions was also considered progression.
SecondaryPart A: Confirmed Investigator Determined Duration of Response (DOR) According to RECIST v1.1From 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 treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.PD:at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study.In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm.Appearance of one/more new lesions was considered progression. Kaplan-Meier method was used.
SecondaryPart B: Confirmed Investigator Determined DOR According to RECIST v1.1From 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)
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 treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.PD:at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study.In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm.Appearance of one/more new lesions was considered progression. Kaplan-Meier method was used.
SecondaryPart B: Confirmed Investigator Determined PSA-DOR, for Prostate CancerFrom 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 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. The confidence interval (CI) was calculated using the complementary log-log transformation method.

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPart A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)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)The full analysis set (FAS) included all participants who received any amount of study drug.Percentage of participantsNUMBER
PRIMARYPart B: Confirmed ORR as Determined by Investigator According to RECIST v1.1
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)
The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.Percentage of participantsNUMBER
PRIMARYPart 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 CancerFrom the first dose of study treatment up to the date of last response assessment (maximum up to 13.5 months)
The FAS included all participants who received any amount of study drug. As prespecified in protocol, this outcome measure was planned to be analyzed only in the Part B: Cohort 7, LV 1.25 mg/kg arm. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participantsNUMBER
SECONDARYPart A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAEFrom start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)The safety analysis set included all participants who received any amount of study drug.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPart B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAEFrom start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)The safety analysis set included all participants who received any amount of study drug.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPart A: Confirmed Investigator Determined Disease Control Rate (DCR) According to RECIST v1.1From 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)The FAS included all participants who received any amount of study drug.Percentage of participantsNUMBER
SECONDARYPart B: Confirmed Investigator Determined DCR According to RECIST v1.1
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)
The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.Percentage of participantsNUMBER
SECONDARYPart A: Confirmed Investigator Determined Duration of Response (DOR) According to RECIST v1.1From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 5.7 months)
The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. No participant had CR or PR in Part A: Cohort 2, LV 2.5 mg/kg arm.
MonthsMEDIAN
SECONDARYPart B: Confirmed Investigator Determined DOR According to RECIST v1.1From 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)
The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. No participant had CR or PR in Part B: Cohort 4, LV 1.25 mg/kg arm, Part B: Cohort 7, LV 1.25 mg/kg arm, Part B: Cohort 1, LV 1.0 mg/kg arm, Part B: Cohort 3, LV 1.0 mg/kg arm and Part B: Cohort 4, LV 1.0 mg/kg arm.
MonthsMEDIAN
SECONDARYPart B: Confirmed Investigator Determined PSA-DOR, for Prostate CancerFrom the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 3 months)
The FAS included all participants who received any amount of study drug. As prespecified in protocol, this outcome measure was planned to be analyzed only in the Part B: Cohort 7, LV 1.25 mg/kg arm. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
MonthsMEDIAN

Results by group332

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
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)Part A: Cohort 1, LV 2.5 mg/kg1095% Confidence Interval 0.3 to 44.5Percentage of participants
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)Part A: Cohort 2, LV 2.5 mg/kg095% Confidence Interval 0.0 to 84.2Percentage of participants
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)Part A: Cohort 3, LV 2.5 mg/kg895% Confidence Interval 0.2 to 36.0Percentage of participants
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)Part A: Cohort 4, LV 2.5 mg/kg1495% Confidence Interval 0.4 to 57.9Percentage of participants
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)Part A: Cohort 5, LV 2.5 mg/kg2095% Confidence Interval 0.5 to 71.6Percentage of participants
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)Part A: Cohort 6, LV 2.5 mg/kg895% Confidence Interval 0.2 to 38.5Percentage of participants
Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1Part B: Cohort 1, LV 1.25 mg/kg695% Confidence Interval 0.2 to 30.2Percentage of participants
Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1Part B: Cohort 2, LV 1.25 mg/kg1395% Confidence Interval 1.6 to 38.3Percentage of participants
Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1Part B: Cohort 3, LV 1.25 mg/kg1195% Confidence Interval 1.3 to 33.1Percentage of participants
Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1Part B: Cohort 4, LV 1.25 mg/kg095% Confidence Interval 0.0 to 23.2Percentage of participants

Participant flow108

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Part ASTARTEDPart A: Cohort 1, LV 2.5 mg/kg10
Part ASTARTEDPart A: Cohort 2, LV 2.5 mg/kg2
Part ASTARTEDPart A: Cohort 3, LV 2.5 mg/kg13
Part ASTARTEDPart A: Cohort 4, LV 2.5 mg/kg7
Part ASTARTEDPart A: Cohort 5, LV 2.5 mg/kg5
Part ASTARTEDPart A: Cohort 6, LV 2.5 mg/kg12
Part ASTARTEDPart B: Cohort 1, LV 1.25 mg/kg0
Part ASTARTEDPart B: Cohort 2, LV 1.25 mg/kg0
Part ASTARTEDPart B: Cohort 3, LV 1.25 mg/kg0
Part ASTARTEDPart B: Cohort 4, LV 1.25 mg/kg0

Adverse events5,976

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersPart A: Cohort 1, LV 2.5 mg/kg0100
otherAnaemiaBlood and lymphatic system disordersPart A: Cohort 2, LV 2.5 mg/kg020
otherAnaemiaBlood and lymphatic system disordersPart A: Cohort 3, LV 2.5 mg/kg2132
otherAnaemiaBlood and lymphatic system disordersPart A: Cohort 4, LV 2.5 mg/kg171
otherAnaemiaBlood and lymphatic system disordersPart A: Cohort 5, LV 2.5 mg/kg151
otherAnaemiaBlood and lymphatic system disordersPart A: Cohort 6, LV 2.5 mg/kg2123
otherAnaemiaBlood and lymphatic system disordersPart B: Cohort 1, LV 1.25 mg/kg2163
otherAnaemiaBlood and lymphatic system disordersPart B: Cohort 2, LV 1.25 mg/kg0160
otherAnaemiaBlood and lymphatic system disordersPart B: Cohort 3, LV 1.25 mg/kg2193
otherAnaemiaBlood and lymphatic system disordersPart B: Cohort 4, LV 1.25 mg/kg2142

Adverse event totals54

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPart A: Cohort 1, LV 2.5 mg/kg910
Total, all-cause mortalityPart A: Cohort 2, LV 2.5 mg/kg22
Total, all-cause mortalityPart A: Cohort 3, LV 2.5 mg/kg1013
Total, all-cause mortalityPart A: Cohort 4, LV 2.5 mg/kg77
Total, all-cause mortalityPart A: Cohort 5, LV 2.5 mg/kg45
Total, all-cause mortalityPart A: Cohort 6, LV 2.5 mg/kg512
Total, all-cause mortalityPart B: Cohort 1, LV 1.25 mg/kg1316
Total, all-cause mortalityPart B: Cohort 2, LV 1.25 mg/kg1316
Total, all-cause mortalityPart B: Cohort 3, LV 1.25 mg/kg1419
Total, all-cause mortalityPart B: Cohort 4, LV 1.25 mg/kg1214

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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