Phase 2 Study of Ubamatamab With or Without Other Drugs for Women With Platinum-Resistant Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are studying an experimental drug called ubamatamab in adult participants with advanced ovarian cancer, including primary peritoneal and fallopian tube cancers. The study aims to evaluate how safe and tolerable ubamatamab is when used alone or in combination with other anti-cancer drugs such as bevacizumab, cemiplimab, fianlimab, REGN10597, and pegylated liposomal doxorubicin PLD. This phase 2 trial also investigates side effects, drug levels in the blood, and immune responses against the study drugs. Participants receive ubamatamab either alone or combined with other specified cancer drugs according to the study protocol. The trial is randomized with multiple experimental arms, each testing different combinations of ubamatamab and additional agents. Treatments are administered per protocol, and the trial includes various schedules and dosing regimens based on the assigned group. Throughout the study, participants undergo regular assessments including tumor response evaluation using RECIST 1.1 criteria, measurements of cancer antigen CA-125 levels, and monitoring for adverse events. Blood samples are collected to measure drug concentrations and detect antibodies against the investigational drugs. Safety is closely monitored for up to three years, and the main outcome is the objective response rate assessed by investigators.

Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer