Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation

Part of paid clinical trials in Santa Monica, California.

Sponsor
Senhwa Biosciences, Inc.
Study ID
NCT04890613
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CX-5461 — DRUG
    150 mg sterile lyophilized powder containing 1% sucrose

Study Details

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.

Key Dates

Start date
Sep 8, 2021
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Main Study Cohort patients receiving CX-5461 at 250mg/m2
    Eligible patients with histologically confirmed pancreatic, ovarian, prostate, or breast cancers with pathogenic/likely pathogenic germline or somatic BRCA1/2 and/or PALB2 mutation and/or genetic alterations in the specified genes will be enrolled to receive CX-5461 at a dosing concentration of 250mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.
  • Experimental: Exploratory cohort patients receiving CX-5461 at 250mg/m2
    Eligible patients with ovarian cancer and pathogenic/likely pathogenic BRCA1 and/or other HRD-associated mutation will be enrolled to receive CX-5461 at a dosing concentration of 250 mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.
  • Experimental: Main Study Cohort patients receiving CX-5461 at 325mg/m2
    After confirming the dose of 250mg/m2 to be safe and tolerable, eligible patients with histologically confirmed pancreatic, ovarian, prostate, or breast cancers with pathogenic/likely pathogenic germline or somatic BRCA1/2 and/or PALB2 mutation and/or genetic alterations in the specified genes will be enrolled to receive CX-5461 at a dosing concentration of 325mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.
  • Experimental: Exploratory cohort patients receiving CX-5461 at 325mg/m2
    After confirming the dose of 250mg/m2 to be safe and tolerable, eligible patients with ovarian cancer and pathogenic/likely pathogenic BRCA1 and/or other HRD-associated mutation will be enrolled to receive CX-5461 at a dosing concentration of 325 mg/m2, delivered as a 60-minute IV infusion on Day 1 and Day 8 of a 28-day cycle.

Primary Outcome Measure

Determination of Recommended Phase 2 Dose (RP2D) [ Time Frame: Safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesSanta MonicaCalifornia90404
Lee Rosen, MD
H. Lee Moffitt Cancer Center and Research Institute HospitalTampaFlorida33612-9497
Heather Han, MD
Dana Farber Cancer InstituteBostonMassachusetts02215
Geoffrey Shapiro, MD
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Ohio State University-James Cancer Hospital and Solove Research InstituteColumbusOhio43202
Sagar Sardesai, MD
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Sarah Taylor, MD

Find similar trials in Santa Monica, CA

By research site
University of California, Los Angeles· Santa Monica, CAH. Lee Moffitt Cancer Center and Research Institute Hospital· Tampa, FLDana Farber Cancer Institute· Boston, MAMemorial Sloan-Kettering Cancer Center· New York, NYOhio State University-James Cancer Hospital and Solove Research Institute· Columbus, OHUPMC Hillman Cancer Center· Pittsburgh, PA

Related Studies