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. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a mi

Trial Details

NCT ID
NCT05941507
Phase
PHASE1 / PHASE2
Sponsor
LigaChem Biosciences, Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • LCB84
  • Anti-PD-1 monoclonal antibody
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

  • Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • Phase 2 Dose Expansion\*: select histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • \*expansion cohort indications to be prioritized based on data from Phase 1 dose escalation.
  • Prior treatment with TROP2-directed therapy is permitted.

For full eligibility, visit ClinicalTrials.gov.

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