Recruiting
Phase 1
Phase 2

RPTR-1-201 & Anti-PD-1

Sponsor:

Repertoire Immune Medicines

Code:

NCT07293754

Conditions

Advanced Malignant Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RPTR-1-201

PD-1 / PD-L1 monoclonal antibody

Study Details

Brief 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.

Conditions

Advanced Malignant Solid Tumor

Study ID

NCT07293754

Start date

Dec 12, 2025

Status verified date

Feb, 2026

Completion date

Apr 15, 2029

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy

Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.

experimental: Combination

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.

Interventions

RPTR-1-201

RPTR-1-201

PD-1 / PD-L1 monoclonal antibody

PD-1/PD-L1 monoclonal antibody

Primary outcome measure

  • 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). ]

Central Contacts and Locations

Locations

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Jacob Goldberg

616-954-5561jacob.goldberg@startresearch.com

More Information

Sponsor

Repertoire Immune Medicines

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • advanced cancer
  • solid tumors
  • immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Repertoire Immune Medicines on 2026-02-17.