Combining PCS6422 with capecitabine for advanced breast cancer treatment

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

This study is testing a new combination of PCS6422 and capecitabine to see if it helps people with advanced breast cancer who can't use standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Processa Pharmaceuticals (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 13 sites (Tucson, Arizona and 12 other locations)
• Trial ID: NCT06568692 on ClinicalTrials.gov

What this trial studies

This Phase 2, open-label, randomized, multi-center study evaluates the combination of PCS6422 with capecitabine against standard capecitabine alone in patients with advanced or metastatic breast cancer. The study focuses on patients who are not eligible for traditional therapies such as anthracyclines or taxanes, as well as other treatments like PD-1 or PARP inhibitors. The aim is to assess both the efficacy and safety of this new treatment regimen in a population that has limited options due to prior treatment resistance or intolerance.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable advanced or metastatic breast cancer, specifically those with triple-negative or hormone receptor-positive, HER2-negative subtypes.

Not a fit: Patients who are eligible for anthracycline- or taxane-containing therapies or other available treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced breast cancer who have exhausted standard therapies.

How similar studies have performed: While this approach is novel, similar studies have shown promise in targeting advanced breast cancer with new combinations of therapies.

Eligibility criteria

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

Where this trial is running

Tucson, Arizona and 12 other locations

• Arizona Oncology Associates — Tucson, Arizona, United States (Recruiting)
• Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
• FOMAT Medical Research — Oxnard, California, United States (Recruiting)
• AP Medical Research — Miami, Florida, United States (Recruiting)
• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
• Northwest Cancer Center — Dyer, Indiana, United States (Recruiting)
• University of Maryland Medical Center (UMMC) — Baltimore, Maryland, United States (Recruiting)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
• Clinical Research Alliance — Westbury, New York, United States (Recruiting)
• Gabrail Cancer Center Research — Canton, Ohio, United States (Recruiting)
• SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
• Texas Oncology PA (Austin) — Austin, Texas, United States (Recruiting)
• Texas Oncology PA (San Antonio) — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Sian Bigora, PharmD

Conditions Breast Cancer; TNBC - Triple-Negative Breast Cancer; HER2-negative Breast Cancer; HR positive; Advanced Breast Cancer; Metastatic Breast Cancer