RecruitingPhase 1Phase 2NCT07293754

An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors

A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors


Sponsor

Repertoire Immune Medicines

Enrollment

150 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
  • At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function as defined in the trial protocol.
  • Ability to provide written informed consent and comply with trial procedures.

Exclusion Criteria5

  • History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
  • Known active leptomeningeal disease or uncontrolled central nervous system metastases.
  • Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
  • Prior allogenic organ transplantation
  • Clinically significant uncontrolled medical or psychiatric condition, that in the opinion of the investigator, would increase risk or interfere with trial participation.

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Interventions

DRUGRPTR-1-201

RPTR-1-201

DRUGPD-1 / PD-L1 monoclonal antibody

PD-1/PD-L1 monoclonal antibody


Locations(1)

START Midwest

Grand Rapids, Michigan, United States

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NCT07293754


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