Status:
RECRUITING
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Lead Sponsor:
Processa Pharmaceuticals
Conditions:
Breast Cancer
TNBC - Triple-Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 metas...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06568692
Start Date
October 2 2024
End Date
October 1 2026
Last Update
June 19 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
3
FOMAT Medical Research
Oxnard, California, United States, 93030
4
AP Medical Research
Miami, Florida, United States, 33165