Phase 1/2 Study of RPTR-1-201 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors

Trial ID: 2025-524010-28-00
Protocol: RPTR-1-201-101
Sponsor: Repertoire Immune Medicines Inc.

Trial statistics

science

test molecules

location_city

research sites

public

countries

medical_information

disease

person_search

investigators

handshake

vendors

Diseases & Conditions

Neoplasm

Objectives

The primary objectives of this study involve evaluating the safety and tolerability of RPTR-1-201 as a monotherapy or in combination with an anti-PD-1 monoclonal antibody during Phase 1, and assessing preliminary antitumor efficacy in Phase 2 for patients with advanced solid tumors.

Secondary objectives include:

Further characterization of the safety profile across all phases.
Assessment of pharmacokinetics, pharmacodynamics, and anti-drug antibodies during Phase 1.
Evaluation of preliminary antitumor activity during Phase 1.
Determination of progression-free survival and time to response during Phase 1b and Phase 2.
Assessment of overall survival during Phase 2.

Participants

This clinical trial involves 45 participants diagnosed with advanced solid tumor. The study population includes both male and female individuals, including vulnerable populations. Inclusion requires participants to be 18 years of age or older with histologically or cytologically confirmed metastatic disease that is not amenable to curative treatment. Selected subjects must have documented disease progression following prior standard-of-care therapy and lack further available treatment options. Eligibility is contingent upon HLA testing confirmation, the presence of at least one measurable lesion according to RECIST v1.1, and an ECOG Performance Status of 1 or less. Additionally, participants must demonstrate adequate organ function and comply with established contraceptive guidelines.

Plans and Procedures

This Phase 1/2 clinical trial is designed to evaluate the safety, tolerability, and preliminary antitumor efficacy of RPTR-1-201, a T cell receptor bispecific therapy, administered as monotherapy or in combination with an anti-PD-1 monoclonal antibody. The study focuses on patients with advanced solid tumors that are not amenable to curative treatment and have progressed following standard-of-care therapy. The Phase 1 component aims to identify dose-limiting toxicities and treatment-emergent adverse events, while also characterizing the pharmacokinetic profile and pharmacodynamics of the investigational product. The Phase 2 component evaluates the objective response rate. Clinical assessments include monitoring for immune-related adverse events, progression-free survival, and overall survival. Study procedures involve a screening period to confirm HLA testing results, histological confirmation of disease, and measurable lesions according to RECIST v1.1. Participants must meet specific Eastern Cooperative Oncology Group performance status criteria and demonstrate adequate organ function. The trial is estimated to conclude by October 2028.

Treatment

The experimental medication RPTR-1-201 is a T cell receptor bispecific therapy administered as a solution for infusion via an intravenous route.

Pembrolizumab is utilized as an anti-PD-1 monoclonal antibody, provided in the pharmaceutical form of KEYTRUDA 25 mg/mL concentrate for solution for infusion for intravenous administration.

Efficacy

The evaluation of preliminary antitumor efficacy in Phase 2 will be conducted using the Objective Response Rate (ORR) as determined by RECIST v1.1. Additional efficacy parameters for Phase 2 include Overall Survival (OS).

In Phase 1, efficacy assessments include the determination of Best Overall Response (BOR), categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), utilizing RECIST v1.1 and iRECIST. Further parameters include Duration of Response (DOR), Disease Control Rate (CR+PR+SD), Progression-Free Survival (PFS), and Time to Response (TTR) as assessed by RECIST v1.1 and iRECIST.

Inclusion and Exclusion Criteria

check_circle

Inclusion Criteria

≥ 18 years old on day of signing informed consent
HLA testing as confirmed by central review
Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment
Participants must have documented radiographic or symptomatic disease progression following receipt of prior standard-of-care therapy for advanced/metastatic disease, and must have no available treatment options that, in the judgment of the Investigator, would be expected to confer clinical benefit or survival advantage.
Participants must have received limited prior lines of systemic therapy for advanced or metastatic disease. Prior therapies must have included standard -of-care regimens if the participant was eligible to receive them, based on tumor type, molecular status, and clinical practice guidelines at the time of treatment.
At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
Adequate organ function as defined in the trial protocol
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Willing and able to comply with contraceptive guidelines

cancel

Exclusion Criteria

Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
Participant received systemic anti-cancer therapy or radiotherapy within 2 weeks prior to start of investigational product
Participant with a known additional malignancy that is progressing or has required active treatment in the last three years.
Participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized.
Administered a live vaccine ≤ 28 days before first dose of investigational product
Concurrent participation in another therapeutic clinical trial
Any medical condition, including alcohol or drug abuse or dependence that would, in the Investigator’s or Sponsor’s assessment, prevent the participant’s participation due to safety concerns, compliance with trial procedure or interpretation of results.