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NOT YET RECRUITING
NCT07583316
PHASE1

A Phase 1 First-in-Human Study of CRPA1A2, a MAGE-A1/HLA-A*02:01 Bispecific T-Cell Engager, in Patients With Solid Tumors

Sponsor: Corregene Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I First-In-Human Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of CRPA1A2, a Bispecific T Cell Engager, in Patients With HLA-A*02:01 and MAGE-A1 Positive Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2026-05-29

Completion Date

2030-09-30

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

CRPA1A2

CRPA1A2 is an investigational bispecific T-cell engager administered by intravenous infusion in 28-day cycles. In Part A, treatment will start at 0.0003 mg/kg and proceed according to protocol-defined escalating dose levels. Weekly dosing is planned, although alternative dosing schedules may be explored during Part A based on emerging PK/PD, safety, tolerability, and efficacy data. A standard dosing approach and/or a step-up dosing strategy may be used. In Part B, participants will receive protocol-defined selected recommended dose(s) for optimization. Treatment will continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, fulfillment of other protocol-defined discontinuation criteria, or study termination, whichever occurs first.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China