Phase 1b Open-Label Trial of Oral REC-617 for Adults with Metastatic or Unresectable RB1-Negative Leiomyosarcoma After Previous Treatment

What this Trial Is About

Researchers are evaluating the study drug REC-617, a selective CDK7 inhibitor, in patients with metastatic or unresectable RB1-negative leiomyosarcoma who have received prior systemic therapy. The study aims to assess the overall response rate ORR to REC-617, along with safety and adverse events, in this specific patient group. Secondary goals include estimating clinical benefit rate, duration of response, progression-free survival, overall survival, and toxicity. Participants will receive REC-617 orally at a dose of 10 mg once daily in an open-label, single-group phase 1b study. The treatment is designed to target tumors confirmed to be RB1-negative, with measurable disease suitable for biopsy. The study excludes children due to lack of dosing and safety data and involves ongoing treatment under medical supervision. During the study, participants will be monitored for safety and adverse events through regular assessments. Tumor response will be evaluated using RECIST v1.1 criteria. Organ function, infection status, cardiac health, and reproductive safety will be assessed prior to and during treatment. The study will continue through completion, with safety data collected for approximately one year. Participants will be required to adhere to contraception guidelines and undergo various laboratory and clinical evaluations.

A Phase 1b, Open-Label Study Of REC-617, A Selective CDK7 Inhibitor, In Patients With Metastatic Or Unresectable RB1-Negative Leiomyosarcoma After Prior Systemic Therapy