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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Number of participants with dose-limiting toxicities and treatment-emergent adverse events. — From first dose through 30 days after last dose of trial treatment. 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.
Objective Response Rate (ORR) per RECIST v1.1 — From first dose until end of treatment or documented disease progression, whichever occurs first (assessed up to 24 months). Proportion of participants with a best overall response of complete response or partial response per RECIST v1.1, as assessed by the investigator.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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