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)

Therapy Setting


Study Design

Open-Label, Non-randomized


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


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: 5.7 months
PFS: 7.3 months (reported as Time To Progression, TTP)

Exploratory analysis prior bevacizumab status:
w/ prior bevacizumab: ORR: 33% (6PR, n=18); DCR: 78% (6PR, 8SD, n=18); PFS: 3.7 months (3.3-NR)
w/o prior bevacizumab: ORR: 57% (4PR, n=7); DCR: 100% (4PR, 3SD, n=7)

Clinically Significant Adverse Events

Serious AE: 1 Gr 4 GI perforation, 1 Gr 4 thrombocytopenia
Grade 3-4 AE: hypertension (38%)


Promising activity of navicixizumab+paclitaxel in heavily pretreated patients


Fu S et al. A phase Ib study of navicixizumab and weekly paclitaxel in heavily pretreated platinum resistant ovarian, primary peritoneal or fallopian tube cancer. SGO (2020) abstract 24.5

FDA Fast Track Designation for Navicixizumab, Press release, 10/07/2019

Fu S et al. A Phase Ib study of navicixizumab & weekly paclitaxel in heavily pre-treated platinum resistant ovarian, primary peritoneal or fallopian tube cancer. Ann Oncol (2018) 29 (suppl_8, abstr 951P) - Poster

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