A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors
NCT07460375 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 191
Last updated 2026-03-10
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
Interventions
- DRUG
-
LCB02A
CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.
Sponsors & Collaborators
-
AntibodyChem Biosciences, Inc.
collaborator UNKNOWN -
LigaChem Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Rodrigo Ruiz Soto, M.D. · LigaChem Biosciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2030-02-28
- Completion
- 2030-08-31
- FDA Drug
- Yes
Countries
- United States
- Canada
- South Korea
Study Locations
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