RecruitingPhase 2NCT06933329

Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor

BicycleTx Limited

Enrollment

73 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Summary

This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new cancer drug called zelenectide pevedotin in patients with certain advanced or metastatic solid tumors that have high levels of a protein called NECTIN4. NECTIN4 is found on the surface of some cancer cells, and this drug is designed to target it directly. **You may be eligible if...** - You have advanced or metastatic solid tumor cancer - Lab tests show your tumor has high levels of NECTIN4 protein - You have already tried standard treatments and they are no longer working - You are an adult in adequate overall health **You may NOT be eligible if...** - Your tumor does not have high NECTIN4 levels - You have serious uncontrolled infections - You have significant nerve damage (neuropathy) - You have severe kidney, liver, or lung problems - You are pregnant or breastfeeding - You have had certain prior cancer treatments that would interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGZelenectide pevedotin

Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.

Locations(29)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

St. Vincent Regional Hospital - Cancer Centers of Montana

Billings, Montana, United States

Clinical Research Alliance, Inc

Westbury, New York, United States

Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio, United States

Honickman Center (Thomas Jefferson University)

Philadelphia, Pennsylvania, United States

Texas Oncology - Central South

Austin, Texas, United States

Texas Oncology - DFW

Dallas, Texas, United States

Virginia Cancer Specialists

Arlington, Virginia, United States

Institut Bergonie

Bordeaux, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Centre Leon Berard

Lyon, France

Institut Curie

Paris, France

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Hopital Foch

Suresnes, France

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Hospital Regional Universitatio (Hospital Civil)

Málaga, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Hospital Clinico Universitatio Lozano Blesa

Zaragoza, Spain

Queen Elizabeth Hospital Birmingham (University Hospitals Birmingham NHS Foundation Trust)

Birmingham, United Kingdom

University College London Hospital

London, United Kingdom

The Royal Marsden Hospital

London, United Kingdom

Northern Centre for Cancer Care, Freeman Hospital (The Newcastle upon Tyne Hospitals NHS Foundation Trust)

Newcastle, United Kingdom

The Royal Marsden Hospital

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06933329