Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation
Senhwa Biosciences, Inc.
Summary
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.
Description
CX-5461 (Pidnarulex), a synthetically-derived small molecule that selectively kills HR-deficient cancer cells through the binding and stabilization of G4 DNA structure. Early phase 1 studies suggest CX-5461 has activity and warrants further investigation in HR-deficient tumors. This study aims to determine the tolerable dose of CX-5461 for phase II studies, amongst an expansion cohorts of BRCA1/2, PALB2 or HRD mutant tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Main study cohort: 1. Histologically or cytologically confirmed malignancy of the pancreas, prostate, breast, or ovary. 2. Documented evidence of pathogenic or likely pathogenic somatic or germline mutation in BRCA1/2 and/or PALB2, and/or any genetic alterations listed below as indicated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory report. The report must be submitted to and approved by study sponsor prior to registration. Other HRD-associated mutations could be eligible if prior approval by the sponsor is granted. ATM, ATR, BARD1, BRCA1, B…
Interventions
- DrugCX-5461
150 mg sterile lyophilized powder containing 1% sucrose
Locations (8)
- University of California, Los AngelesSanta Monica, California
- H. Lee Moffitt Cancer Center and Research Institute HospitalTampa, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan-Kettering Cancer CenterNew York, New York
- Ohio State University-James Cancer Hospital and Solove Research InstituteColumbus, Ohio
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania