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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

NCT07583316 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Lung Cancer (Locally Advanced or Metastatic)
  • Esophagus Cancer
  • Head and Neck Cancer
  • Hepatocellular Carcinoma (HCC)

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.

Sponsors & Collaborators

  • Corregene Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2030-03-30
Completion
2030-09-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583316 on ClinicalTrials.gov