A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled…
Conditions studied
Advanced Solid Tumors
About this study
This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.
Interventions
- Drug: LCB84 — TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
- Drug: Anti-PD-1 monoclonal antibody — anti-PD-1 Ab
Primary outcomes
- Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2) (Up to 48 months)
- Recommended Phase 2 Dose of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1) (Up to 24 months)
- Objective Response Rate (Phase 2) (Up to 24 months)
- Clinical Benefit Rate (Phase 2) (Up to 24 months)
- Duration of Response (Phase 2) (Up to 24 months)
- Time to Progression (Phase 2) (Up to 24 months)
- Progression Free Survival (Phase 2) (Up to 24 months)
- Overall Survival (Phase 2) (Up to 24 months)
Eligibility information
Study locations
- Cedars Sinai Medical Center, Los Angeles, California 90048 United States
- Dana Farber Cancer Institute, Boston, Massachusetts 02115 United States
- University of Michigan, Ann Arbor, Michigan 48109 United States
- Tennessee Oncology, Nashville, Tennessee 37203 United States
- Mary Crowley Cancer Research, Dallas, Texas 75230 United States
- University of Texas Southwestern Medical Center, Dallas, Texas 75390 United States
- MD Anderson Cancer Center, Houston, Texas 77030 United States
- Princess Margaret Cancer Centre, Toronto, Ontario M5G 2M9 Canada
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.