Monte Rosa starts MRT-2359 prostate trial
- Monte Rosa Therapeutics dosed the first patient in a Phase 2 trial of MRT-2359 plus apalutamide for metastatic castration-resistant prostate cancer.
- The MODeFIRe-1 study will enroll up to 25 patients with AR mutation-positive mCRPC.
- Monte Rosa stated that prior combination data showed PSA responses in 5 of 5 AR-mutant patients in an earlier study.
Monte Rosa Therapeutics (NASDAQ:GLUE) announced that the first patient has been dosed in MODeFIRe-1, a Phase 2 trial evaluating investigational molecular glue degrader MRT-2359 with apalutamide in patients with AR mutation-positive metastatic castration-resistant prostate cancer.
The trial will enroll up to 25 patients with mCRPC who previously received a second-generation androgen receptor inhibitor and will evaluate treatment responses and safety outcomes.
The study will assess PSA responses, RECIST responses, duration of response, radiographic progression-free survival, PSA progression-free survival, and safety, while enrollment in the prior expansion arm with enzalutamide has been completed.
Monte Rosa stated that updated data from six AR-mutant patients in the previous expansion arm is expected by year-end.
The company previously reported that the enzalutamide combination study showed PSA responses in 5 of 5 AR-mutant patients, a 100% disease control rate, and two RECIST responses among heavily pretreated patients.
Monte Rosa Therapeutics develops molecular glue degraders designed to target disease-related proteins, with MRT-2359 being evaluated in cancer indications including AR mutation-positive prostate cancer.
