A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Rgenta Therapeutics Inc
Summary
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
Description
This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once-daily RGT-61159 in patients with advanced R/R ACC or R/R CRC for whom standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. RGT-61159 is an oral, small molecule MYB inhibitor.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed ACC or CRC * Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation * Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry * Patients with CRC must have locally R/R advanced or…
Interventions
- DrugRGT-61159
Oral MYB inhibitor
Locations (10)
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Washington University School of MedicineSt Louis, Missouri
- Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- MD Anderson Cancer CenterHouston, Texas