Early-phase test of RPTR-1-201 for advanced solid tumors
A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors
This trial will try RPTR-1-201 alone and with an anti‑PD‑1 antibody to see if it is safe and helps adults with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Repertoire Immune Medicines Industry-sponsored |
| Locations | 1 site (Grand Rapids, Michigan) |
| Trial ID | NCT07293754 on ClinicalTrials.gov |
What this trial studies
This is a phase 1/2, dose-escalation and dose-expansion trial of RPTR-1-201 given as monotherapy and in combination with an anti‑PD‑1 monoclonal antibody in adults with locally advanced or metastatic solid tumors. The study enrolls patients with at least one measurable lesion per RECIST v1.1 and ECOG performance status 0–1 and requires adequate organ function. The dose-escalation portion will establish safety, tolerability, and a recommended phase 2 dose, while expansion cohorts will gather preliminary antitumor activity data. Primary endpoints focus on safety and tolerability with secondary assessments of objective response by RECIST.
Who should consider this trial
Good fit: Adults with histologically or cytologically confirmed locally advanced or metastatic solid tumors not amenable to curative treatment, with at least one measurable lesion, ECOG 0–1, and adequate organ function are eligible.
Not a fit: Patients with active, clinically significant autoimmune disease requiring systemic immunosuppression, uncontrolled CNS metastases or leptomeningeal disease, recent other malignancies, or prior allogeneic organ transplant are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, RPTR-1-201 could offer a new treatment option that shrinks tumors or prolongs disease control for some patients with advanced solid tumors.
How similar studies have performed: Combining novel immunotherapies with anti‑PD‑1 antibodies has demonstrated activity in several cancer types, but RPTR-1-201 is a novel agent and its clinical efficacy remains unproven.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Grand Rapids, Michigan
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.