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

June 18, 2025 updated by: Processa Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with Cap vs. standard dose of Cap alone in 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. 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 have been treated with chemotherapy in the metastatic setting.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
    • California
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Valkyrie Clinical Trials
        • Principal Investigator:
          • David Berz, MD
        • Contact:
      • Oxnard, California, United States, 93030
        • Recruiting
        • Fomat Medical Research
        • Principal Investigator:
          • Nawazish Khan, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33165
      • Tampa, Florida, United States, 33612
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Recruiting
        • Northwest Cancer Center
        • Principal Investigator:
          • Shruti Singh, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center (UMMC)
        • Contact:
        • Principal Investigator:
          • Katherine Tkaczuk, MD
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
        • Principal Investigator:
          • Mridula George, MD
    • New York
      • Westbury, New York, United States, 11590
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center Research
        • Principal Investigator:
          • Nashat Gabrail, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
        • Principal Investigator:
          • Denise Yardley, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78731
      • San Antonio, Texas, United States, 78240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 years at Screening

  2. Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:

    1. Patients with triple-negative breast cancer, advanced or metastatic
    2. Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer
  3. Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1
  4. Other therapies are not indicated (eg, resistant or intolerant to taxanes and/or an anthracycline-containing regimen) for treatment of advanced or metastatic breast cancer
  5. Has a life expectance of at least 24 weeks
  6. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening
  7. Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before C1D1 (Note: labs will also be repeated pre-dose on C1D1 to confirm eligibility): a. Hemoglobin ≥9 g/dL (≥90 g/L) b. Adequate renal function by estimated glomerular filtration rate (eGFR) defined as a creatinine clearance >50 mL/min (>0.84 mL/s) (Cockcroft-Gault equation) and normalized to body surface area c. Peripheral absolute neutrophil count (ANC) of ≥1.5×109/L d. Platelet count of ≥100×109/L without growth factor/transfusion e. Total bilirubin <1.5× upper limit of normal (ULN); or ≤3×ULN if the patient has Gilbert's disease f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5×ULN, with liver metastasis <5×ULN g. International normalized ratio (INR) <1.5 and prothrombin time (PT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant h. Activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless both of the following conditions are met: i. Patient is receiving anticoagulant therapy, and ii. PT or PTT is within therapeutic range of intended use of anticoagulants

Exclusion Criteria:

  1. Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
  2. Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
  3. Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
  4. Received DPD inhibitor within 4 weeks prior to C1D1
  5. Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity

  6. Cardiac:

    1. Has history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) results, in the Medical Monitor or Investigator's opinion
    2. Has prolonged QTc (with Fridericia's correction) of >480 msec performed at Screening
    3. Has a history of prolonged QTc interval, ventricular tachycardia/fibrillation or significant ventricular arrhythmia, or Torsades de Pointes, or a history of ventricular ablation for arrhythmia
    4. Has congenital long QT syndrome or a family history of long QT syndrome

    5. Has other clinically significant cardiac disease including, but not limited to, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery ≤12 months prior to randomization, congestive heart failure

      • Class II per the New York Heart Association, or history of myocarditis
  7. Is pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCS6422 40 mg + Capecitabine 300 mg
Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days
Drug: PCS6422 and capecitabine
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
Experimental: PCS6422 40 mg + Capecitabine 450 mg or 150 mg
Fixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days
Drug: PCS6422 and capecitabine
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
Active Comparator: Capecitabine 2000 mg/m2
Standard capecitabine dose at 1000 mg/m2 BID
Drug: Capecitabine
Commercially available capecitabine is a commonly used oral fluoropyrimidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Objective Response Rate (ORR)
Time Frame: Up to 24 weeks post End of Treatment (EoT)
The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Up to 24 weeks post End of Treatment (EoT)
Number of patients with adverse events (AEs)
Time Frame: During treatment, an average of 8 months
Frequency, duration, and severity of AEs across treatment groups
During treatment, an average of 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Disease Control Rate (DCR)
Time Frame: Up to 24 weeks post End of Treatment (EoT)
The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1
Up to 24 weeks post End of Treatment (EoT)
Evaluation of Duration of Response (DOR)
Time Frame: Up to 24 weeks post End of Treatment (EoT)
Up to 24 weeks post End of Treatment (EoT)
Evaluation of Time to Response (TTR)
Time Frame: Every 12 weeks during treatment
Every 12 weeks during treatment
Evaluation of Progression Free Survival (PFS)
Time Frame: Up to 24 weeks post End of Treatment (EoT)
Up to 24 weeks post End of Treatment (EoT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Processa Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCS6422-BC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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