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
M.D. Anderson Cancer Center
Summary
To learn if the study drug REC-617 can help to control LMS. The safety of REC-617 will also be studied.
Description
Primary Objectives The primary objective of this trial is to assess ORR to REC-617 in RB1-negative leiomyosarcoma, as defined by RECIST v1.1. Secondary objectives * To estimate clinical benefit rate, duration of response, duration of complete response, duration of stable disease per best response by RECIST 1.1 * To estimate median PFS and PFS rate at 12 - 24 weeks * To estimate median OS and OS rate at 12 months * To assess toxicity per CTCAE v6
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria A. Disease Characteristics * Histologically confirmed leiomyosarcoma (any site of origin). * RB1-negative tumor, as assessed by immunohistochemistry (IHC) with a cutoff of 0% versus any expression Participants will have measurable diseases by RECIST 1.1. Previously ablated/ radiated/treated areas can only be counted towards measurable disease if there is unequivocal progression after directed therapy. * Participant will have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases, as confirmed by a radiologist, if appropriate, and as deemed safe by the…
Interventions
- DrugREC617
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas