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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CRPA1A2 — DRUG
  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.

Study Details

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.

Key Dates

First listed

May 13, 2026

Start date

May 29, 2026

Status verified

Apr 2026

Primary completion

Mar 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

192 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A Dose Escalation
  Participants will receive CRPA1A2 by intravenous infusion in 28-day cycles in the dose-escalation part of the study. Treatment will start at 0.0003 mg/kg and proceed through protocol-defined escalating dose levels using a standard dosing approach and/or a step-up dosing strategy, as applicable. This arm is designed to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity and to support identification of the recommended dose(s) for optimization (RDO\[s\]).
• Experimental: Part B RDO 1
  Participants with selected tumor types will be randomized in Part B to receive CRPA1A2 at Recommended Dose for Optimization 1 (RDO 1), administered by intravenous infusion in 28-day cycles according to the protocol-defined regimen, to further characterize safety and preliminary anti-tumor activity.
• Experimental: Part B RDO 2
  Participants with selected tumor types will be randomized in Part B to receive CRPA1A2 at Recommended Dose for Optimization 2 (RDO 2), administered by intravenous infusion in 28-day cycles according to the protocol-defined regimen, to further characterize safety and preliminary anti-tumor activity.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) in Part A [ Time Frame: Day 28 ]

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