A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Trial ID # NCT03030287
Phase Ib
Drug Class Angiogenesis Inhibitors: VEGF/DLL4
Drug Name Navicixizumab
Alternate Drug Names OMP-305B83, anti-DLL4/VEGF bispecific monoclonal antibody OMP-305B83
Drugs in Trial Navicixizumab, Paclitaxel
Eligible Participant

Platinum resistant or refractory ovarian cancer with > 2 prior therapies

Patients Enrolled

44; median 4 prior therapies (2-12); 68% w/ prior bevacizumab

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, RP2D, evaluated per RECIST


Exploratory: Xernaâ„¢ TME Panel Biomarker (B+: angiogenic or immune-suppressed TME, B-: immune-active or immune-desert TME)


RP2D: Pac 80mg/m2 on days 1,8,15 + Nav 3 mg/kg on days 1,15 of every 28 day cycle

ORR: 43.2% (1CR, 18PR, n=44)
DCR: 77.3% (1CR, 18PR, 15SD, n=44)
DoR: 6.0 months
PFS: 7.2 months

Exploratory analysis prior bevacizumab status, Xerna™ TME Panel Biomarker status:
w/ prior bevacizumab (n=30): ORR: 33% (10PR); DCR: 66.7% (10PR, 10SD); DoR: 6.3 months; PFS: 5.4 months
w/o prior bevacizumab (n=14): ORR: 57% (1CR, 8PR); DCR: 100% (1CR, 8PR, 5SD); DoR: 5.6 months; PFS: 7.6 months
Xerna™ TME Panel B+ (n=13): ORR: 62% (8PR), DCR: 100%; PFS: 9.2 months
Xerna™ TME Panel B- (n=20): ORR: 25% (1CR, 4PR, n=20), DCR: 65%; PFS: 3.9 months

Clinically Significant Adverse Events

Serious AE: 1 Gr 4 GI perforation, 1 Gr 4 duodenal ulcer, 1 Gr 4 thrombocytopenia, 1 Gr 3 thrombocytopenia
Grade 3-4 AE: hypertension (41%)


Promising activity of navicixizumab+paclitaxel in heavily pretreated patients


Fu S et al. Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. J Clin Oncol (2022) 40(23):2568-2577

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