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

NCT ID NCT04890613

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Montreal, Quebec, H2X 0C2, Canada

    Contact

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    RECRUITING

    Tampa, Florida, 33612-9497, United States

    Contact

  • 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

    Contact

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

    Contact

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

    Contact

  • University of California, Los Angeles

    RECRUITING

    Santa Monica, California, 90404, United States

    Contact