A Phase 1/2 interventional study of RPTR-1-201 and PD-1 / PD-L1 monoclonal antibody in Advanced Malignant Solid Tumor, sponsored by Repertoire Immune Medicines. Recruiting at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Repertoire Immune Medicines · Phase 1/2, Interventional, and Treatment
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.
Repertoire Immune Medicines is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol.
Drug: RPTR-1-201
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 · Drug: PD-1 / PD-L1 monoclonal antibody
RPTR-1-201
PD-1/PD-L1 monoclonal antibody
Number of participants with dose-limiting toxicities and treatment-emergent adverse events.
Number of participants experiencing dose-limiting toxicities and treatment-emergent adverse events, including events considered related to RPTR-1-201, graded according to CTCAE v5.0.
Time frame: From first dose through 30 days after last dose of trial treatment.
Objective Response Rate (ORR) per RECIST v1.1
Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
Time frame: From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months).
Incidence and severity of adverse events and abnormal safety assessments.
Incidence and severity of adverse events, including immune-related adverse events, and abnormal safety assessments (clinical laboratory tests, ECGs, vital signs).
Time frame: From first dose through 30 days after last dose of trial treatment
Pharmacokinetics of RPTR-1-201
Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201.
Time frame: First dose until end of treatment (assessed up to 24 months).
Progression Free Survival (PFS)
Time from first dose of RPTR-1-201 to the earliest date of documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: From first dose until disease progression, death, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Overall survival (OS)
Time from first dose of RPTR-1-201 to death from any cause.
Time frame: From first dose until death from any cause or end of trial follow-up, whichever occurs first (assessed up to 36 months).
Time to Response
Time from first dose of RPTR-1-201 to the first documented complete response or partial response per RECIST v1.1.
Time frame: From first dose until first documented response, disease progression, or end of trial follow-up, whichever occurs first (assessed up to 24 months).
Pharmacokinetics of RPTR-1-201 (AUC)
Characterization of the pharmacokinetic area under the curve of RPTR-1-201
Time frame: First dose until end of treatment (assessed up to 24 months)
Immunogenicity of RPTR-1-201
Characterization of the incidence of anti-drug antibodies of RPTR-1-201.
Time frame: First dose until end of treatment (assessed up to 24 months)
Plan to share: No — Individual participant data will not be shared for this trial.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Repertoire Immune Medicines