A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Stopped early · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04032704

Run by

Seagen Inc.

People needed

205

Starts

2019-10-09

Expected to finish

2023-11-28

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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 stage disease.
• Participants with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are not eligible
• 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.
• Participants with known EGFR, ALK, ROS, BRAF, tropomyosin receptor kinase (TRK), or other actionable mutations are not eligible
• 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

You may not qualify if…

• Active concurrent malignancy or a previous malignancy within the past 3 years
• Any anticancer therapy within 3 weeks of starting study treatment. Participants who are/were on adjuvant hormonal therapy for the treatment of malignancies with negligible risk of metastases are eligible.
• Known active central nervous system lesions
• Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher)
• Ongoing sensory or motor neuropathy of Grade ≥2
• Has received prior radiotherapy within 2 weeks of start of study treatment
• History of interstitial lung disease.

Where it is running

• 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
• University of Maryland — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• HealthPartners Institute — Saint Louis Park, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Valley Hospital, The / Luckow Pavilion — Paramus, New Jersey, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Weill Cornell Medicine — New York, New York, United States
• Stony Brook University Cancer Center — Stony Brook, New York, United States
• FirstHealth of the Carolinas — Pinehurst, North Carolina, United States
• Gabrail Cancer Center Research, LLC — Canton, Ohio, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Saint Francis Hospital / Bon Secours - South Carolina — Greenville, South Carolina, United States
• Erlanger Oncology and Hematology — Chattanooga, Tennessee, United States
• Tennessee Oncology-Nashville/Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Joe Arrington Cancer Research and Treatment Center — Lubbock, Texas, United States
• Ironwood Cancer & Research Centers - Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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