RecruitingPhase 2NCT06568692

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer


Sponsor

Processa Pharmaceuticals

Enrollment

90 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called PCS6422 combined with capecitabine (an oral chemotherapy tablet) in people with advanced or metastatic breast cancer. It targets patients whose cancer has stopped responding to other standard treatments like taxanes or anthracyclines. **You may be eligible if:** - You are 18 or older - You have advanced or metastatic breast cancer that is either triple-negative, or hormone receptor positive/HER2 negative - Your cancer cannot be surgically removed - Other standard treatments are no longer working or are not suitable for you - You are in good general health (ECOG score 0 or 1) with at least 24 weeks life expectancy - Your organ function (bone marrow, liver, kidney) is adequate **You may NOT be eligible if:** - You are currently able to receive taxanes or anthracycline-based chemotherapy - You have untreated or actively progressing brain metastases - Your organ function does not meet required levels - You are pregnant or breastfeeding 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

DRUGPCS6422 and capecitabine

PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.

DRUGCapecitabine

Commercially available capecitabine is a commonly used oral fluoropyrimidine.


Locations(13)

Arizona Oncology Associates

Tucson, Arizona, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

FOMAT Medical Research

Oxnard, California, United States

AP Medical Research

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwest Cancer Center

Dyer, Indiana, United States

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Clinical Research Alliance

Westbury, New York, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology PA (Austin)

Austin, Texas, United States

Texas Oncology PA (San Antonio)

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06568692


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