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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Processa Pharmaceuticals
Study ID
NCT06568692
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PCS6422 and capecitabine — DRUG
    PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer.
  • Capecitabine — DRUG
    Commercially available capecitabine is a commonly used oral fluoropyrimidine.

Study Details

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.

Key Dates

Start date
Oct 2, 2024
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PCS6422 40 mg + Capecitabine 300 mg
    Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days
  • Experimental: 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
  • Active Comparator: Capecitabine 2000 mg/m2
    Standard capecitabine dose at 1000 mg/m2 BID

Primary Outcome Measure

Evaluation of Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks post End of Treatment (EoT) ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesTucsonArizona85711
Aisha Ahmed, MD
[email protected]
520-866-0206
Valkyrie Clinical TrialsLos AngelesCalifornia90067
Chemyn Cortez
[email protected]
424-535-1874
David Berz, MD (PRINCIPAL_INVESTIGATOR)
FOMAT Medical ResearchOxnardCalifornia93030
Kelly Schlingensiepen
[email protected]
805-483-1185
Nawazish Khan, MD (PRINCIPAL_INVESTIGATOR)
AP Medical ResearchMiamiFlorida33165
Eloy Roman, MD
[email protected]
305-400-8899
Moffitt Cancer CenterTampaFlorida33612
Shere Wallace
[email protected]
813-745-4933
Spencer Zions
[email protected]
Tracey O'Connor, MD (PRINCIPAL_INVESTIGATOR)
Northwest Cancer CenterDyerIndiana46311
Mariela Study Coordinator
[email protected]
219-924-8178
Shruti Singh, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical Center (UMMC)BaltimoreMaryland21201
Nancy Tait
[email protected]
410-328-3546
Katherine Tkaczuk, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Shameema Mohamed
[email protected]
732-754-7788
Mridula George, MD (PRINCIPAL_INVESTIGATOR)
Clinical Research AllianceWestburyNew York11590
James D'Olimpio, MD
[email protected]
Gabrail Cancer Center ResearchCantonOhio44718
Carrie Smith
[email protected]
330-417-8231
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Kristy Long
[email protected]
615-712-3268
Denise Yardley, MD (PRINCIPAL_INVESTIGATOR)
Texas Oncology PA (Austin)AustinTexas78731
Kathryn Hudson, MD
[email protected]
512-427-9400
Texas Oncology PA (San Antonio)San AntonioTexas78240
Emmalind Aponte, MD
[email protected]
210-595-5300

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Arizona Oncology Associates· Tucson, AZValkyrie Clinical Trials· Los Angeles, CAFOMAT Medical Research· Oxnard, CAAP Medical Research· Miami, FLMoffitt Cancer Center· Tampa, FLNorthwest Cancer Center· Dyer, IN

Related Studies