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

Purpose

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.

Condition

  • Advanced Malignant Solid Tumor

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Monotherapy 		Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.
  • Drug: RPTR-1-201
    RPTR-1-201
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.
  • Drug: RPTR-1-201
    RPTR-1-201
  • Drug: PD-1 / PD-L1 monoclonal antibody
    PD-1/PD-L1 monoclonal antibody

Recruiting Locations

START Midwest
Grand Rapids 4994358, Michigan 5001836 49546
Contact:
Jacob Goldberg
616-954-5561
jacob.goldberg@startresearch.com

More Details

Status
Recruiting
Sponsor
Repertoire Immune Medicines

Study Contact