New drug targets Hard-to-Treat cancers in people with BRCA2 or PALB2 mutations

NCT ID NCT04890613

Recruiting now Disease control Sponsor: Senhwa Biosciences, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental drug called CX-5461 (Pidnarulex) in people with advanced solid tumors (pancreatic, prostate, breast, or ovarian) that have specific BRCA2 or PALB2 gene mutations. The main goal is to find a safe and tolerable dose for future studies. Researchers will also look for signs that the drug shrinks tumors and monitor quality of life. About 52 participants will receive the drug by IV infusion twice per month.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CX-5461 (Pidnarulex), a drug given by IV infusion
What this could lead to: If successful, this could point toward a new treatment option for people with certain hard-to-treat cancers linked to BRCA2 or PALB2 mutations.
What could go wrong: This is an early Phase 1b trial with only 52 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects, and it is too soon to know if it will work for a broader population.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm fallopian tube cancer malignant pancreatic neoplasm ovarian cancer pancreatic neoplasm primary peritoneal carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED SOLID TUMOR

Contacts and locations

Locations

Centre hospitalier de l'Université de Montréal (CHUM)
RECRUITING

Montreal, Quebec, H2X 0C2, Canada
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital
RECRUITING

Tampa, Florida, 33612-9497, United States
Memorial Sloan-Kettering Cancer Center
WITHDRAWN

New York, New York, 10065, United States
Ohio State University-James Cancer Hospital and Solove Research Institute
RECRUITING

Columbus, Ohio, 43202, United States
Princess Margaret Cancer Centre
RECRUITING

Toronto, Ontario, M5G 1X6, Canada
UPMC Hillman Cancer Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of California, Los Angeles
RECRUITING

Santa Monica, California, 90404, United States

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