An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors (RaPTR-101)

February 12, 2026 updated by: Repertoire Immune Medicines

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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 Criteria:

  • 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.
  • Other protocol-defined inclusion and exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy
Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.
Drug: RPTR-1-201
RPTR-1-201
Experimental: Combination
Participants receive RPTR-1-201 in combination with an approved or investigational PD-1 monoclonal antibody at doses and schedules defined by the trial protocol.
Drug: PD-1 / PD-L1 monoclonal antibody
PD-1/PD-L1 monoclonal antibody
Drug: RPTR-1-201
RPTR-1-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
Time Frame: From first dose through 30 days after last dose of trial treatment.
Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0.
From first dose through 30 days after last dose of trial treatment.
Objective Response Rate (ORR) per RECIST v1.1
Time Frame: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events and abnormal safety assessments.
Time Frame: From first dose through 30 days after last dose of trial treatment
Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs).
From first dose through 30 days after last dose of trial treatment
Pharmacokinetics of RPTR-1-201
Time Frame: First dose until end of treatment (assessed up to 24 months).
Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201.
First dose until end of treatment (assessed up to 24 months).
Progression Free Survival (PFS)
Time Frame: From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Time from first dose of RPTR-1-201 to the earliest date of documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Overall survival (OS)
Time Frame: From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
Time from first dose of RPTR-1-201 to death from any cause.
From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
Time to Response
Time Frame: From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Time from first dose of RPTR-1-201 to the first documented complete response or partial response per RECIST v1.1.
From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Pharmacokinetics of RPTR-1-201 (AUC)
Time Frame: First dose until end of treatment (assessed up to 24 months)
Characterization of the pharmacokinetic area under the curve of RPTR-1-201
First dose until end of treatment (assessed up to 24 months)
Immunogenicity of RPTR-1-201
Time Frame: First dose until end of treatment (assessed up to 24 months)
Characterization of the incidence of anti-drug antibodies of RPTR-1-201.
First dose until end of treatment (assessed up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repertoire Immune Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

April 15, 2029

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RPTR-1-201-101
  • 2025-524010-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared for this trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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