Table of contents
- Trial overview
- Who is being studied
- What is being tested
- Trial phases and endpoints
- Study status and size
Trial overview
The clinical trial identified as NCT07293754 is an early phase study of RPTR-1-201 in advanced solid tumors.[1] It is an interventional study, which means the researchers assign a treatment and then measure what happens.[1]
The trial is Phase 1/2, so it combines an early safety stage with an early efficacy stage.[1] The status is listed as Authorised.[1]
Who is being studied
The condition being studied is advanced solid tumor.[1] This means the trial is not limited to one cancer type, but to people with advanced solid tumors as a group.[1]
The trial data do not give detailed inclusion or exclusion rules, but the target population is people with advanced solid tumors.[1]
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.[1] 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.[1]
This setup lets researchers compare how RPTR-1-201 performs alone and when paired with another cancer treatment.[1] 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.[1]
Trial phases and endpoints
In Phase 1, the main goal is to evaluate safety and tolerability.[1] Tolerability means how well people can handle the treatment without having too many problems.[1]
The Phase 1 primary outcome is the number of participants with dose-limiting toxicities and treatment-emergent adverse events.[1] 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.[1]
In Phase 2, the study looks at preliminary antitumor efficacy, which means early signs that the treatment may help against cancer.[1] The Phase 2 primary outcome is Objective Response Rate, or ORR, measured by RECIST v1.1.[1] ORR is the percentage of patients whose tumors shrink or disappear, and RECIST v1.1 is a standard way to measure tumor response.[1]
Study status and size
The trial is listed as Authorised and plans to enroll 97 participants.[1] This is a relatively small early phase study, which is typical when researchers are first checking safety and early activity.[1]
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.[1]
