NCT07460375

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 191 (estimated)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	LCB02A	CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.

Timeline

• Start date: 2026-08-01
• Primary completion: 2030-02-01
• Completion: 2030-08-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

6 sites across 3 countries: United States, Canada, South Korea

Regulatory

• FDA-regulated drug study