RecruitingPhase 1Phase 2NCT05941507

A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors


Sponsor

LigaChem Biosciences, Inc.

Enrollment

300 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing LCB84, a new type of targeted therapy called an antibody-drug conjugate (ADC) that delivers chemotherapy directly to cancer cells carrying a protein called TROP2, either alone or combined with an immunotherapy drug, in people with advanced solid tumors. **You may be eligible if...** - You have a histologically confirmed advanced solid tumor that has stopped responding to standard treatments - For the expansion phase: you have a specific tumor type identified as eligible by the study - You are in adequate general health and your organs are functioning well enough for treatment **You may NOT be eligible if...** - You have received too many prior lines of treatment or certain prior TROP2-targeted therapies - You have active brain metastases (cancer spread to the brain) - You have serious lung disease or other significant organ dysfunction - You are pregnant or breastfeeding 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.

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Interventions

DRUGLCB84

TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug

DRUGAnti-PD-1 monoclonal antibody

anti-PD-1 Ab


Locations(8)

Cedars Sinai Medical Center

Los Angeles, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Tennessee Oncology

Nashville, Tennessee, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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

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NCT05941507


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