A Phase 3 Randomized Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator s Choice (IC) in Patients with Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

Brief description of study

This is a Phase 3 randomized, open-label study testing the investigational drug Rinatabart Sesutecan (Rina-S) in people with endometrial cancer. Rinatabart Sesutecan (Rina-S), also known as PRO1184 or GEN1184, is a novel antibody-drug conjugate (ADC) designed to target folate receptor alpha (FRa). Participants in this study will be randomly assigned to receive either Rina-S or the investigator's choice of treatment (IC), meaning each participant has an equal chance of being assigned to either group. The investigator's choice of treatment could include various chemotherapy options or other approved therapies for endometrial cancer. Both the participants and researchers will know which treatment the participants are receiving. Participants will have already received platinum-based chemotherapy and PD(L)-1 therapy, but their cancer has either come back or continued to grow. The purpose of this trial is to compare how well Rina-S works against endometrial cancer compared to the current chemotherapy options available, like paclitaxel or doxorubicin, which are already used to treat this type of cancer.

In this study, participants will be randomly assigned to one of two treatment groups in a 1:1 ratio. The randomization will be based on ECOG performance status, FRa expression, number of previous treatments and investigator’s choice of chemotherapy. One group will receive Rina-S and the other group will receive the investigator’s choice of chemotherapy (IC). Before randomization, the investigator (doctor) will choose which chemotherapy drug (paclitaxel or doxorubicin) to use for each patient if they are assigned to the IC group. Participants cannot switch between the treatment groups once they are assigned to a group.

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicines. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-00666
ClinicalTrials.gov Identifier: NCT07166094
Principal Investigator: Michelle Diane Swanson Lightfoot.
Other Investigators: Kathleen M Lutz, Christina Grace Wilson, Rupal Bhana, Marina Stasenko, Emeline Mariam Aviki, Kent Chan, Edward A Jimenez, Erin Annette Reese, Bhavana Pothuri, Fabia Brisard Pierrot, Cindy Corbo, Whitfield B. Growdon, Sarah Saerohm Lee, Marilyn Huang, Anastasiya Apanasyuk, Kelly A Levine, Leslie R Boyd, Victoria Helen Dowd, Alexander A Hindenburg.


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