A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
NCT ID: NCT06568692
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-10-02
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCS6422 40 mg + Capecitabine 300 mg
Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days
PCS6422 and capecitabine
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
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
PCS6422 and capecitabine
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
Capecitabine 2000 mg/m2
Standard capecitabine dose at 1000 mg/m2 BID
Capecitabine
Commercially available capecitabine is a commonly used oral fluoropyrimidine.
Interventions
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PCS6422 and capecitabine
PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
Capecitabine
Commercially available capecitabine is a commonly used oral fluoropyrimidine.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Processa Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PCS6422-BC-01
Identifier Type: -
Identifier Source: org_study_id
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