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A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

NCT04032704•Seagen Inc.

Summary

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.

Detailed Description

This trial is designed to assess the antitumor activity, safety, and tolerability of LV alone and with pembrolizumab, for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled: Cohort 1: small cell lung cancer (SCLC) Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous) Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous) Cohort 4: head and neck squamous cell carcinoma (HNSCC) Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma Participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death, whichever comes first.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All Cohorts
•* Measurable disease according to RECIST v1.1 as assessed by the investigator
•* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
•Cohort 1: SCLC (Parts A and B)
•* Must have extensive stage disease
•* Must have disease progression during or following prior platinum-based systemic chemotherapy for extensive stage disease;
•* No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage
•* May have received prior anti-PD(L)1 therapy
•Cohort 2: NSCLC-squamous (Parts A and B)
•* Must have unresectable locally advanced or metastatic disease
+13 more criteria

Exclusion Criteria

•* No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
•* Must have received prior anti-PD(L)1 therapy, unless contraindicated
•Cohort 3: NSCLC-nonsquamous (Parts A and B)
•* Must have unresectable locally advanced or metastatic disease
•* Must have disease progression during or following systemic therapy
•* Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR
•* Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease.
•* Must have had prior platinum-based chemotherapy
•* No more than 1 prior line of cytotoxic chemotherapy for their advanced disease
•* Must have received prior anti-PD(L)1 therapy, unless contraindicated
+35 more criteria

Locations (66)

Ironwood Cancer & Research Centers - Chandler

Chandler, Arizona, United States

Adventist Health White Memorial

Los Angeles, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, United States

GenesisCare USA

Jacksonville, Florida, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

IACT Health

Columbus, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Decatur Memorial Hospital - Illinois

Decatur, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Key Dates

Start Date

October 9, 2019

Primary Completion Date

November 28, 2023

Completion Date

November 28, 2023

Last Updated

March 10, 2025

Enrollment

205

ACTUAL participants

Conditions

Small Cell Lung CancerNon-small Cell Lung Cancer, SquamousNon-small Cell Lung Cancer, Non-squamousHead and Neck Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaProstate CancerMelanoma

Interventions

ladiratuzumab vedotin

DRUG

pembrolizumab

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)