In short
Clinical trials are investigating RPTR-1-201 in people with advanced solid tumors. These studies are looking at safety, tolerability, and early signs of antitumor activity for RPTR-1-201 used alone and with an anti-PD-1 antibody. The main target population is adults with advanced solid tumors.
Key points
- RPTR-1-201 is being studied in an authorised Phase 1/2 trial for advanced solid tumors. The trial looks at RPTR-1-201 both alone and together with an anti-PD-1 monoclonal antibody. Phase 1 focuses on safety and tolerability, including dose-limiting toxicities and treatment-emergent adverse events. Phase 2 looks at early antitumor activity using Objective Response Rate, or ORR. The study plans to enroll 97 participants.
Trial overview
The clinical trial identified as NCT07293754 is an early phase study of RPTR-1-201 in advanced solid tumors. It is an interventional study, which means the researchers assign a treatment and then measure what happens.
The trial is Phase 1/2, so it combines an early safety stage with an early efficacy stage. The status is listed as Authorised.
Who is being studied
The condition being studied is advanced solid tumor. This means the trial is not limited to one cancer type, but to people with advanced solid tumors as a group.
The trial data do not give detailed inclusion or exclusion rules, but the target population is people with advanced solid tumors.
What is being tested
RPTR-1-201 is being studied as monotherapy, meaning by itself, and also in combination with an anti-PD-1 monoclonal antibody. The brief summary also says the combination study includes an anti-PD-1 monoclonal antibody and lists KEYTRUDA as a drug used by intravenous infusion.
This setup lets researchers compare how RPTR-1-201 performs alone and when paired with another cancer treatment. The trial data do not describe how the treatment works in the body, so this article focuses only on the research goals stated in the study record.
Trial phases and endpoints
In Phase 1, the main goal is to evaluate safety and tolerability. Tolerability means how well people can handle the treatment without having too many problems.
The Phase 1 primary outcome is the number of participants with dose-limiting toxicities and treatment-emergent adverse events. Dose-limiting toxicities are side effects severe enough to limit treatment, and treatment-emergent adverse events are medical problems that start or worsen after treatment begins.
In Phase 2, the study looks at preliminary antitumor efficacy, which means early signs that the treatment may help against cancer. The Phase 2 primary outcome is Objective Response Rate, or ORR, measured by RECIST v1.1. ORR is the percentage of patients whose tumors shrink or disappear, and RECIST v1.1 is a standard way to measure tumor response.
Study status and size
The trial is listed as Authorised and plans to enroll 97 participants. This is a relatively small early phase study, which is typical when researchers are first checking safety and early activity.
Because the trial is early phase, the main purpose is not to prove final benefit, but to collect early safety and response data that can guide later research.