Study of GV20-0251 in Participants With Solid Tumor Malignancies
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.
Eligibility Criteria
Inclusion Criteria: * Before conducting any study-specific procedures, voluntarily sign an informed consent form. * Be able and willing to participate throughout the entire study period and comply with study procedures. * participants ≥18 years of age * Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy) * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) * For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression * ECOG performance status of 0 or 1 before C1D1 * Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible * Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results wi