Early-phase test of RPTR-1-201 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2, dose-escalation and dose-expansion trial of RPTR-1-201 given as monotherapy and in combination with an anti‑PD‑1 monoclonal antibody in adults with locally advanced or metastatic solid tumors. The study enrolls patients with at least one measurable lesion per RECIST v1.1 and ECOG performance status 0–1 and requires adequate organ function. The dose-escalation portion will establish safety, tolerability, and a recommended phase 2 dose, while expansion cohorts will gather preliminary antitumor activity data. Primary endpoints focus on safety and tolerability with secondary assessments of objective response by RECIST.

Why it matters

Who can join: the full rules

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

Where it's running

• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• START New York-Long Island
  Lake Success, New York, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting
• START Dublin
  Dublin, Ireland Recruiting
• START Lisbon
  Lisbon, Portugal Recruiting
• START Barcelona
  Barcelona, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.