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

NCT07293754 · tracked via the Priya Life Science Portugal tracker

Sponsor

Repertoire Immune Medicines

Phase

Phase 1/2

Started

2025-12-12

Last updated

2026-09-28

Condition(s) studied

Advanced Malignant Solid Tumor

Investigational drug(s) / intervention(s)

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

RPTR-1-201: RPTR-1-201

PD-1 / PD-L1 monoclonal antibody: PD-1/PD-L1 monoclonal antibody

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of participants with dose-limiting toxicities and treatment-emergent adverse events. — 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.
Objective Response Rate (ORR) per RECIST v1.1 — 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.

Trial sites (12)

Facility	City	Region	Status
START Midwest	Grand Rapids	Michigan	Recruiting
START New York-Long Island	Lake Success	New York	Recruiting
START San Antonio	San Antonio	Texas	Recruiting
START Dublin	Dublin	Ireland	Recruiting
START Lisbon	Lisbon	Portugal	Recruiting
START Barcelona	Barcelona	Spain	Recruiting
START Rioja	Logroño	Spain	Recruiting
Clinica Universidad de Navarra - Madrid	Madrid	Spain	Recruiting
START Madrid-CIOCC	Madrid	Spain	Recruiting
START Madrid-FJD	Madrid	Spain	Recruiting
Clinica Universidad de Navarra - Pamplona	Pamplona	Spain	Recruiting
INCLIVA Instituto de Investigación Sanitaria VLC	Valencia	Spain	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293754 on ClinicalTrials.gov ↗ ← All trials in Portugal