RecruitingPhase 1Phase 2NCT07460375

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors

A First-in-Human Phase 1/2, Dose Escalation and Dose Expansion Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of Claudin18.2 (CLDN18.2)-Directed Antibody-Drug Conjugate (ADC) LCB02A in Patients With CLDN18.2-positive Advanced Solid Tumors


Sponsor

LigaChem Biosciences, Inc.

Enrollment

191 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory to standard of care therapy or for whom no standard of care options are available. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of single agent LCB02A is determined, the study will proceed to Phase 2 expansion cohorts in selected tumor types.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LCB02A for people with advanced solid tumors. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

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

DRUGLCB02A

CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.


Locations(8)

Mass General Hospital

Boston, Massachusetts, United States

START New York - Long Island

Lake Success, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Seoul National University Hospital

Seoul, South Korea

ASAN Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07460375


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