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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524010-28-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | Participants receive RPTR-1-201 at doses and schedules defined by the trial protocol. |
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| Combination | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPTR-1-201 | Drug | RPTR-1-201 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From first dose through 30 days after last dose of trial treatment |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
Individual participant data will not be shared for this trial.
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| PD-1 / PD-L1 monoclonal antibody |
| Drug |
PD-1/PD-L1 monoclonal antibody |
|
| Pharmacokinetics of RPTR-1-201 |
Characterization of the pharmacokinetic maximum observed concentration of RPTR-1-201. |
| 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. | 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. | 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. | 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 | 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. | First dose until end of treatment (assessed up to 24 months) |