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Recruiting NCT07293754

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

Phase I / Phase II Interventional Advanced Malignant Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RPTR-1-201, PD-1 / PD-L1 monoclonal antibody.
Who it may be relevant to
Registry conditions: Advanced Malignant Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug RPTR-1-201
    RPTR-1-201
  • Drug PD-1 / PD-L1 monoclonal antibody
    PD-1/PD-L1 monoclonal antibody

Primary outcome measures

  • 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.]
  • 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).]
Secondary outcome measures (7)
  • Incidence and severity of adverse events and abnormal safety assessments. [Time frame: 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).]
  • 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).]
  • 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 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).]
  • Pharmacokinetics of RPTR-1-201 (AUC) [Time frame: 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • START Midwest — Grand Rapids

Identifiers

NCT: NCT07293754 · RPTR-1-201-101 · 2025-524010-28-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗