A Study of Navicixizumab Monotherapy or in Combination in Patients With Select Advanced Solid Tumors

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
OncXerna Theraputics, Inc.
Study ID
NCT05453825
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • navicixizumab+paclitaxel — BIOLOGICAL
    navicixizumab 3 mg/kg Q2W; paclitaxel 80 mg/m2 weekly
  • navicixizumab+irinotecan — BIOLOGICAL
    navicixizumab 3 mg/kg Q2W; irinotecan 180 mg/m2 Q2W
  • navicixizumab monotherapy — BIOLOGICAL
    navicixizumab 3 mg/kg Q2W

Study Details

This is a study of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced cancer. Patients will be enrolled into one of the following cancer cohorts: * Cohort A: CRC * Cohort B: Gastric and GEJ cancer * Cohort C: TNBC * Cohort D: Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer (ovarian cancer)

Key Dates

Start date
Aug 5, 2022
Status verified
Jan 2023
Primary completion
Apr 15, 2024
Completion
Dec 15, 2024

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination navicixizumab + paclitaxel
    Gastric/GEJ and TNBC cancer patients will be assigned to this treatment arm.
  • Experimental: Combination navicixizumab + irinotecan
    CRC patients will be assigned to this treatment arm.
  • Experimental: Navicixizumab monotherapy
    CRC,TNBC and ovarian cancer patients will be assigned to this treatment arm.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Genesis Cancer CenterHot SpringsArkansas71913-
Keck Medicine of USCLos AngelesCalifornia90033-
Moffitt Cancer CenterTampaFlorida33612-
Northside HospitalAtlantaGeorgia30322-
Hematology Oncology ClinicBaton RougeLouisiana70809-
New York University - Langone Health - Perlmutter Cancer CenterNew YorkNew York10016-
The Zangmeister Cancer CenterColumbusOhio43219-
Tennessee OncologyNashvilleTennessee37203-

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