RecruitingPhase 1NCT04890613

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

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation


Sponsor

Senhwa Biosciences, Inc.

Enrollment

52 participants

Start Date

Sep 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called CX-5461, which targets the machinery that cancer cells use to make proteins, in patients whose tumors have DNA repair defects (such as BRCA1/2 or PALB2 mutations). These defects make cancer cells more vulnerable to this type of drug. **You may be eligible if...** - You are 18 or older with cancer of the pancreas, prostate, breast, or ovary (main cohort), or ovarian/fallopian tube/peritoneal cancer (exploratory cohort) - Your tumor has a documented mutation in a DNA repair gene such as BRCA1, BRCA2, PALB2, ATM, CHEK2, or others on the approved list - Your disease has measurably progressed recently - You have adequate blood counts and organ function - You are willing to undergo tumor biopsies before and during treatment **You may NOT be eligible if...** - You have a known photosensitivity condition (you must agree to strict sun protection) - You are pregnant or breastfeeding - You have active brain metastases or bowel obstruction - You have a known heart rhythm abnormality (prolonged QT interval) - You have active eye surface disease or a history of certain eye conditions - You have had recent major surgery or are on strong CYP3A4 inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCX-5461

150 mg sterile lyophilized powder containing 1% sucrose


Locations(8)

University of California, Los Angeles

Santa Monica, California, United States

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Ohio State University-James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT04890613


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