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 — BIOLOGICALnavicixizumab 3 mg/kg Q2W; paclitaxel 80 mg/m2 weekly
- navicixizumab+irinotecan — BIOLOGICALnavicixizumab 3 mg/kg Q2W; irinotecan 180 mg/m2 Q2W
- navicixizumab monotherapy — BIOLOGICALnavicixizumab 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 + paclitaxelGastric/GEJ and TNBC cancer patients will be assigned to this treatment arm.
- Experimental: Combination navicixizumab + irinotecanCRC patients will be assigned to this treatment arm.
- Experimental: Navicixizumab monotherapyCRC,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
- OncXerna Therapeutics781-907-7810
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Genesis Cancer Center | Hot Springs | Arkansas | 71913 | - |
| Keck Medicine of USC | Los Angeles | California | 90033 | - |
| Moffitt Cancer Center | Tampa | Florida | 33612 | - |
| Northside Hospital | Atlanta | Georgia | 30322 | - |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | 70809 | - |
| New York University - Langone Health - Perlmutter Cancer Center | New York | New York | 10016 | - |
| The Zangmeister Cancer Center | Columbus | Ohio | 43219 | - |
| Tennessee Oncology | Nashville | Tennessee | 37203 | - |
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