Actively Recruiting
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
Led by Senhwa Biosciences, Inc. · Updated on 2026-04-28
52
Participants Needed
8
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed cancer of the pancreas, prostate, breast, or ovary
- Documented pathogenic or likely pathogenic mutation in BRCA1/2, PALB2, or other specified HRD-associated genes confirmed by a certified laboratory report
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 14 days before registration
- Radiographic evidence of disease progression within 28 days before registration
- Measurable disease according to RECIST v1.1 criteria
- Adequate bone marrow, kidney, and liver function based on specified lab values within 14 days before registration
- Willingness to undergo tumor biopsies before treatment and at disease progression (or submission of prior biopsy if available)
- Life expectancy of more than 3 months from registration
- Ability to provide written informed consent
- Willingness and ability to comply with study protocol including treatment and scheduled visits
- Female participants of childbearing potential must have a negative pregnancy test before registration
- Use of effective contraception or true abstinence for females of childbearing potential and sexually active males before and during treatment and for 6 months after last dose
- No limit on prior therapies, including prior PARP inhibitor treatment
- Clinically stable at study entry
You will not qualify if you...
- For pancreatic cancer, tumors other than adenocarcinoma histology are excluded
- Presence of malignant bowel obstruction
- Untreated or unstable brain or meningeal metastases; stable brain metastases allowed if asymptomatic and off corticosteroids for at least 10 days
- Unresolved toxicity greater than CTCAE grade 1 from prior cancer treatments, except certain hematologic toxicities, grade 1 or 2 neuropathy, and alopecia
- Severe or uncontrolled diseases such as active infections, unstable respiratory, cardiac, neurological, liver, kidney disease, or psychiatric illness that may affect compliance
- Treatment with investigational agents other than PARP inhibitors within 30 days, or PARP inhibitors within 14 days before study drug
- Immunocompromised status including certain HIV or active hepatitis infections, with some exceptions
- Recent major thoracic or abdominal surgery within 14 days or incomplete wound healing
- Concurrent systemic anti-cancer or biological therapies not allowed; palliative radiotherapy allowed with restrictions
- Active second malignancy requiring treatment or confounding safety assessment unless discussed with medical monitor
- Known photosensitivity disorders or unwillingness to follow strict sun protection measures
- Pregnancy or nursing
- Active ocular surface disease or history of cicatricial conjunctivitis
- Recent limited field radiotherapy within 1 week or wide field radiotherapy within 4 weeks before first dose
- Prolonged QT/QTc interval or risk factors for Torsades de Pointes
- Use of medications that prolong QT/QTc interval or strong CYP3A4 inhibitors or inducers
- Other malignancies within 5 years except certain noninvasive or surgically cured cancers
- Incidental prostate cancer with low PSA and no hormonal treatment may be included after sponsor discussion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
University of California, Los Angeles
Santa Monica, California, United States, 90404
Actively Recruiting
2
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States, 33612-9497
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Withdrawn
5
Ohio State University-James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43202
Actively Recruiting
6
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
7
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1X6
Actively Recruiting
8
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C2
Actively Recruiting
Research Team
S
Serena Robinson
CONTACT
H
Hylee Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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