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

NCT ID: NCT07293754

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2029-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Malignant Solid Tumor

Keywords

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advanced cancer solid tumors immunotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Monotherapy

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

Group Type EXPERIMENTAL

RPTR-1-201

Intervention Type DRUG

RPTR-1-201

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.

Group Type EXPERIMENTAL

RPTR-1-201

Intervention Type DRUG

RPTR-1-201

PD-1 / PD-L1 monoclonal antibody

Intervention Type DRUG

PD-1/PD-L1 monoclonal antibody

Interventions

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RPTR-1-201

RPTR-1-201

Intervention Type DRUG

PD-1 / PD-L1 monoclonal antibody

PD-1/PD-L1 monoclonal antibody

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Repertoire Immune Medicines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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RPTR-1-201-101

Identifier Type: -

Identifier Source: org_study_id

2025-524010-28-00

Identifier Type: CTIS

Identifier Source: secondary_id