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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
LigaChem Biosciences, Inc.
Study ID
NCT07460375
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 10, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
191 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LCB02A monotherapy

Primary Outcome Measure

Safety of LCB02A (Phase 1 and 2) [ Time Frame: Up to 48 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mass General HospitalBostonMassachusetts02214
Harshabad Singh, MD (PRINCIPAL_INVESTIGATOR)
START New York - Long IslandLake SuccessNew York11042
Geraldine O'Sullivan Coyne, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29406
A. Craig Lockhart, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Mariela Blum Murphy, MD (PRINCIPAL_INVESTIGATOR)

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