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

Study Identifier:
RPTR-1-201-101
CT.gov Identifier:
NCT07293754
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-524010-28-00
Study Contact Information:
N/A
Recruiting

Considering participating in a START clinical trial?

Get Started

Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Combination
    • Read More
  • Drug: 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: Drug: PD-1 / PD-L1 monoclonal antibody
  • Drug: PD-1/PD-L1 monoclonal antibody
  • Drug: Drug: RPTR-1-201
  • Drug: RPTR-1-201
  • Drug: EXPERIMENTAL: Monotherapy
  • Drug: Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START La Rioja
    Logroño, La Rioja, Spain, 26006
    Investigator
    Maria de Miguel
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Go to page