AN OPEN-LABEL STUDY OF GV20-0251 IN PATIENTS WITH ADVANCED AND/OR REFRACTORY SOLID TUMOR MALIGNANCIES
Brief description of study
This is a Phase 1 non-randomized, open label, multicenter study to be conducted in two parts (Parts A and B). Part A involves a classical 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities (DLTs) and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 (RP2D) of GV20-0251. Dose escalation will occur sequentially over the doses of 0.5, 1, 3, 6, and 10 mg/kg until the criteria for reaching the MTD are met. At the start of each new dose level, there must be = 72 hours between the initial treatment of the sentinel participant enrolled in the Cohort and subsequent participant treatment. Cycle 1 will define the DLT period that governs dose escalation. Part B is a cohort expansion in which eligible participants will be treated at the RP2D of GV20-0251 selected in Part A to further characterize the safety, tolerability, pharmacokinetics, target occupancy, and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in participants with selected malignancies. The protocol will be amended prior to the initiation of Part B with additional details (e.g., which malignancies will be selected for evaluation, etc.). Additional parts or cohorts investigating GV20-0251 with a checkpoint inhibitor might be added in the future through a protocol amendment. The study consists of a Screening Period, a Treatment Period, an End of Treatment (EOT) Visit, two Safety Follow-Up Visits (30-day and 90-day) and a Survival Follow-Up Period. The Screening Period begins after a participant signs the informed consent form and includes a review of inclusion and exclusion criteria and procedures performed within a 28-day interval to assess participant eligibility and to obtain baseline measurements. Eligible participants enter the Treatment Period that consists of repeating 21-day treatment cycles. Study drug treatment cycles will continue for as long as a participant does not meet study drug discontinuation criteria. Upon discontinuing study drug, participants undergo an EOT visit. Two Safety Follow-Up visits will occur at 30-days and 90-days after the EOT visit. After the 90-day Safety Follow-Up visit the participant will then be contacted every 12 weeks during the Survival Follow-Up period until the participant withdraws consent, is lost to follow up, death or study closure. The study will be considered complete when all participants have discontinued study drug and 90-day Safety Follow-Up visits have been completed.
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