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NCT Number: NCT07293754

An Early Phase Trial of RPTR-1-201 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.

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Key information

Conditions

Advanced Malignant Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location status: Recruiting

Location contact

Jacob Goldberg

CONTACT

[email protected]

616-954-5561

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RPTR-1-201

Drug

RPTR-1-201

PD-1 / PD-L1 monoclonal antibody

Drug

PD-1/PD-L1 monoclonal antibody

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Repertoire Immune Medicines

Industry

Registry information

Official study title

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

Acronym: RaPTR-101

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 19, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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