An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors (RaPTR-101)

Repertoire Immune Medicines

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Malignant Solid Tumor

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07293754

2025-524010-28-00 (EU Trial (CTIS) Number)

RPTR-1-201-101

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Monotherapy

Experimental group

Description:

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

Treatment:

Drug: RPTR-1-201

Combination

Experimental group

Description:

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.

Treatment:

Drug: RPTR-1-201

Drug: PD-1 / PD-L1 monoclonal antibody