OBI Pharma, Inc
This is a 3-part study. Phase 1a (dose escalation) is designed to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and putative recommended phase 2 dose (RP2D) of study drug as monotherapy. Phase 1b (Cohort Expansion) is intended to further characterize the safety and preliminary antitumor activity of the putative RP2D of OBI-902 in selected tumor types. Phase 2 (Randomized Dose Optimization Cohorts) is intended to determine the optimal RP2D of OBI-902 in selected tumor types, before advancing to larger Phase 3 trials.
Inclusion Criteria: 1. Male or female participants, 18 years of age or older at the time of consent 2. Provide written informed consent prior to performing any study-related procedure 3. Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies 4. Participants must have been treated with established standard-of-care therapy, andphysicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the source documen…
OBI-902 is an antibody-drug conjugate study drug