This is a Phase I, first-in-human, open-label study of CRPA1A2, a bispecific T-cell engager, in participants with HLA-A\*02:01-positive and MAGE-A1-positive advanced solid tumors. The study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of CRPA1A2, and to identify recommended dose(s) for further evaluation. The study consists of 2 parts: a dose escalation part (Part A) and a dose optimization part (Part B). In Part A, participants will receive escalating doses of CRPA1A2 to determine the recommended dose(s) for optimization, with additional backfill cohorts permitted. In Part B, 2 to 3 selected recommended dose(s) will be further evaluated in participants with selected tumor types to better characterize safety and preliminary anti-tumor activity. CRPA1A2 will be administered by intravenous infusion in 28-day cycles, starting at 0.0003 mg/kg. Weekly dosing is planned, although alternative dosing schedules may be explored based on emerging data. Treatment will continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, other discontinuation criteria are met, or study termination.
Age range
18 Years
Sex
ALL
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Incidence of dose-limiting toxicities (DLTs) in Part A
Timeframe: Day 28
Incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and clinically significant changes in safety tests
Timeframe: up tp 30 months
Maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO[s]) and dosing schedule in Part A
Timeframe: Day 1, Day 8, Day 15, Day 28
Objective response rate (ORR) per RECIST v1.1 in Part B
Timeframe: up to 30 months
Duration of response (DoR) per RECIST v1.1 in Part B
Timeframe: up to 30 months