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

NCT06568692 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PCS6422-BC-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Breast Cancer; TNBC - Triple-Negative Breast Cancer; HER2-negative Breast Cancer

Keywords

HR positive; Advanced Breast Cancer; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of Objective Response Rate (ORR)

  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)

  Frequency, duration, and severity of AEs across treatment groups

  During treatment, an average of 8 months

Secondary Outcomes (4)

• Evaluation of Disease Control Rate (DCR)

  Up to 24 weeks post End of Treatment (EoT)

• Evaluation of Duration of Response (DOR)

  Up to 24 weeks post End of Treatment (EoT)

• Evaluation of Time to Response (TTR)

  Every 12 weeks during treatment

• Evaluation of Progression Free Survival (PFS)

  Up to 24 weeks post End of Treatment (EoT)

Study Arms (3)

PCS6422 40 mg + Capecitabine 300 mg

EXPERIMENTAL

Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days

Drug: PCS6422 and capecitabine

PCS6422 40 mg + Capecitabine 450 mg or 150 mg

EXPERIMENTAL

Fixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days

Drug: PCS6422 and capecitabine

Capecitabine 2000 mg/m2

ACTIVE COMPARATOR

Standard capecitabine dose at 1000 mg/m2 BID

Drug: Capecitabine

Interventions

PCS6422 and capecitabine DRUG

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

PCS6422 40 mg + Capecitabine 300 mg; PCS6422 40 mg + Capecitabine 450 mg or 150 mg

Capecitabine DRUG

Commercially available capecitabine is a commonly used oral fluoropyrimidine.

Capecitabine 2000 mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years at Screening
• Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included:
• Patients with triple-negative breast cancer, advanced or metastatic
• Patients with hormone receptor (HR) positive, ER positive, HER2 negative advanced or metastatic breast cancer
• Has measurable disease in accordance with RECIST 1.1 obtained by imaging within 28 days prior to C1D1
• 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
• Has a life expectance of at least 24 weeks
• Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 at screening
• 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

You may not qualify if:

• Received any line of treatment for advanced or metastatic breast cancer within 21 days or 5 half-lives (whichever is longer) prior to randomization
• Currently receiving any hormone replacement therapy, unless discontinued within 21 days prior to randomization
• Received IV 5-FU or oral 5-FU analog in the 4 weeks prior to C1D1
• Received DPD inhibitor within 4 weeks prior to C1D1
• Has homozygous or compound heterozygous DPYD variants that result in complete or near-complete absence of DPD activity
• Cardiac:
• Has history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) results, in the Medical Monitor or Investigator's opinion
• Has prolonged QTc (with Fridericia's correction) of \>480 msec performed at Screening
• 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
• Has congenital long QT syndrome or a family history of long QT syndrome
• 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
• Is pregnant or breastfeeding

Sponsors & Collaborators

• Processa Pharmaceuticals: lead

Study Sites (13)

Arizona Oncology Associates

Tucson, Arizona, 85711, United States

RECRUITING

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

FOMAT Medical Research

Oxnard, California, 93030, United States

RECRUITING

AP Medical Research

Miami, Florida, 33165, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Northwest Cancer Center

Dyer, Indiana, 46311, United States

RECRUITING

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, 21201, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Clinical Research Alliance

Westbury, New York, 11590, United States

RECRUITING

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology PA (Austin)

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology PA (San Antonio)

San Antonio, Texas, 78240, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Sian Bigora, PharmD

CONTACT

410-693-6844; sbigora@processapharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (13)