navixizumab (OMP-305B83)

Up to 30 patients will be enrolled to each CRC cohort from approximately 8 sites in the US and will receive 3 mg/kg navicixizumab alone (Cohort A1) or in combination with irinotecan (180 mg/m2 on Days 1 and 15 of a 28-day cycle, Cohort A2). Secondary efficacy endpoints include overall survival, time to response, disease control rate, duration of response, and the relationship between antitumor activity of navicixizumab and Xerna TME Panel biomarker subtypes. Clinical trial information: NCT05453825.

Eligible TNBC patients will have locally advanced or metastatic disease and have received at least 2 and no more than 4 prior lines of standard therapy for metastatic disease, including immunotherapy (for PD-L1 positive TNBC patients), and sacituzumab govitecan...Up to 30 patients will be enrolled to each TNBC cohort from approximately 8 sites in the US and will receive 3 mg/kg navicixizumab alone (Cohort C1) or in combination with paclitaxel (80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle) (Cohort C2)...Cohort continuation and future evaluation decisions will be guided by the boundaries identified by a sequential monitoring procedure. Secondary efficacy endpoints include overall survival, time to response, disease control rate, duration of response, and the relationship between antitumor activity of navicixizumab and Xerna TME Panel™ biomarker subtypes.

P1b | N=44 | NCT03030287 | Sponsor: OncoMed Pharmaceuticals, Inc | "Navicixizumab plus paclitaxel showed promising and durable clinical activity in a heavily pretreated patient population regardless of prior treatment (median of four prior therapies) Overall response rate (ORR) across all evaluable patients: 43% (19/44), ORR in patients previously treated with bevacizumab (Avastin®): 33% (10/30), ORR in patients previously treated with a PARP inhibitor: 45% (9/20),11 of 19 patients with partial or complete response had progressive disease as best response to immediate prior therapy. Median duration of response: 6 months. B+ classification showed enrichment of patients with tumor response. ORR in B+ vs. B- patients: 62% (8/13) vs. 25% (5/20), Best response of progressive disease in B+ vs. B- patients: 0% (0/13) vs. 30% (6/20), Median progression-free survival in B+ vs. B- patients: 9.2 months vs. 3.9 months."

P3, N=400, Ongoing, OncXerna Therapeutics, Inc.