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 — DRUGCLDN18.2-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
- David Browning+1-615-975-7776
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mass General Hospital | Boston | Massachusetts | 02214 | Harshabad Singh, MD (PRINCIPAL_INVESTIGATOR) |
| START New York - Long Island | Lake Success | New York | 11042 | Geraldine O'Sullivan Coyne, MD (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29406 | A. Craig Lockhart, MD (PRINCIPAL_INVESTIGATOR) |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Mariela Blum Murphy, MD (PRINCIPAL_INVESTIGATOR) |
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