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

NCT07293754 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: RPTR-1-201-1012025-524010-28-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

advanced cancer; solid tumors; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose-limiting toxicities and treatment-emergent adverse events.

  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.

  From first dose through 30 days after last dose of trial treatment.

• Objective Response Rate (ORR) per RECIST v1.1

  Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.

  From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).

Secondary Outcomes (7)

• Incidence and severity of adverse events and abnormal safety assessments.

  From first dose through 30 days after last dose of trial treatment

• Pharmacokinetics of RPTR-1-201

  First dose until end of treatment (assessed up to 24 months).

• Progression Free Survival (PFS)

  From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).

• Overall survival (OS)

  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

  From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).

Study Arms (2)

Monotherapy

EXPERIMENTAL

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

Drug: RPTR-1-201

Combination

EXPERIMENTAL

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: RPTR-1-201; Drug: PD-1 / PD-L1 monoclonal antibody

Interventions

RPTR-1-201 DRUG

RPTR-1-201

Combination; Monotherapy

PD-1 / PD-L1 monoclonal antibody DRUG

PD-1/PD-L1 monoclonal antibody

Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Repertoire Immune Medicines: lead

Study Sites (1)

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 19, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): April 15, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)