Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Eligible patients will be enrolled into two cohorts; Main study cohort: Patients with histologically-confirmed pancreatic, ovarian, prostate, or breast cancers with pathogenic/likely pathogenic germline BRCA2 and/or PALB2 mutation. Exploratory cohort: women with ovarian cancer and pathogenic/likely pathogenic BRCA1 and/or other HRD-associated mutation. An initial 16 eligible patients for the main cohort and 10 eligible patients for the exploratory cohort will be enrolled to receive CX-5461 at 250mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle. Upon completion of enrollment of all patients in the initial arms, if there are no safety concerns after review of the safety data, another two arms will open to enroll an additional 16 patients for the main cohort and 10 patients for the exploratory cohort to receive CX-5461 at 325mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 de...
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.
Tracking Information
- NCT #
- NCT04890613
- Collaborators
- Not Provided
- Investigators
- Study Director: John Soong, MD, FCAP Senhwa Biosciences
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