| Trial ID # | NCT03639246 |
| Phase | Ib/II |
| Drug Class | Growth Factor Inhibitors: Gas6 |
| Drug Name | Batiraxcept |
| Alternate Drug Names | anti-AXL fusion protein AVB-S6-500, AVB-S6-500, AVB-500 |
| Drugs in Trial | Batiraxcept, Liposomal doxorubicin, Paclitaxel |
| Eligible Participant | Platinum resistant ovarian cancer |
| Patients Enrolled | 53; AVB-S6-500+Pac: 23, median 2 prior therapies, 56% w/ prior Bev; AVB-S6-500+PLD: 30, median 1 prior therapy; 40% w/ prior Bev |
| Therapy Setting | Recurrence |
| Study Design | Double Blind, Randomized |
| Endpoints | ORR, DCR, PFS, evaluated per RECIST |
| Biomarkers | Exploratory: AVB-S6-500 levels in relation to minimal efficacious concentration (MEC) |
| Efficacy | RP2D for AVB-S6-500: 15 mg/kg Q2W (84% of patients achieves MEC) AVB-S6-500+Pac vs AVB-S6-500+PLD: Exploratory analysis, prior Bev, AVB-S6-500 serum trough levels, serum sAxl/Gas6 ratio: AVB-S6-500+Pac; PFI<3 months vs 3≤PFI<6 months: AVB-S6-500+Pac; trough levels above MEC vs below MEC: |
| Clinically Significant Adverse Events | AVB-S6-500+Pac vs AVB-S6-500+PLD: |
| Conclusion | AVB-S6-500+paclitaxel or liposomal doxorubicin is safe; the combination of AVB-S6-500+paclitaxel is most effective and best response is seen in patients without prior bevacizumab |
| Reference | Fuh KC et al. Phase 1b study of GAS6/AXL inhibitor (AVB-500) in recurrent, platinum-resistant ovarian carcinoma. J Clin Oncol (2021) 39 (suppl 15; abstr 5566) Fuh KC et al. Poster Fuh KC et al. Phase 1b study of AVB-500 in combination with paclitaxel or pegylated liposomal doxorubicin platinum-resistant recurrent ovarian cancer. Gynecol Oncol (2021) 163(2):254-261 |