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Trial Title:
A Phase 2 Study of PCS6422 with Capecitabine in Patients with Advanced or Metastatic Breast Cancer
NCT ID:
NCT06568692
Condition:
Breast Cancer
TNBC - Triple-Negative Breast Cancer
HER2-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Capecitabine
Conditions: Keywords:
HR positive
Advanced Breast Cancer
Metastatic Breast Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PCS6422 and capecitabine
Description:
PCS6422 is an experimental drug that, when combined with capecitabine, may make the
immune response more active against cancer.
Arm group label:
PCS6422 40 mg + Capecitabine 300 mg
Arm group label:
PCS6422 40 mg + Capecitabine 450 mg or 150 mg
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Commercially available capecitabine is a commonly used oral fluoropyrimidine.
Arm group label:
Capecitabine 2000 mg/m2
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
Myo Zaw
Phone:
424-535-1874
Email:
myo.zaw@vctcare.com
Facility:
Name:
Clinical Research Alliance
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Contact:
Last name:
James D'Olimpio, MD
Email:
jdolimpio@researchcra.com
Facility:
Name:
Gabrail Cancer Center Research
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Smith
Phone:
330-417-8231
Email:
csmith@gabrailcancercenter.com
Start date:
October 2, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Processa Pharmaceuticals
Agency class:
Industry
Source:
Processa Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06568692
