- |||||||||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Jun 14, 2024 P1/2, N=12, Active, not recruiting, Trial completion date: Aug 2024 --> Aug 2025 Trial completion date: Feb 2025 --> Aug 2024 | Trial primary completion date: Feb 2025 --> Aug 2024
- |||||||||| batiraxcept (AVB-500) / Aravive
Trial completion date, Trial primary completion date, Combination therapy: AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov) - Jun 12, 2024 P1, N=36, Not yet recruiting, Trial completion date: Feb 2025 --> Aug 2024 | Trial primary completion date: Feb 2025 --> Aug 2024 Trial completion date: Jan 2034 --> Jun 2034 | Trial primary completion date: Jan 2029 --> Jun 2029
- |||||||||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
P1 data, Journal, Combination therapy: Phase 1b study of batiraxcept in combination with durvalumab in patients with platinum-resistant ovarian cancer. (Pubmed Central) - May 10, 2024 P1/2 Batiraxcept effectively reduced serum GAS6 levels at 1-h post-treatment, resulting in trough levels below the limit of detection in all cases but one. In conclusion, the combination of batiraxcept and durvalumab was safe and tolerable but did not demonstrate anti-tumor activity in a heterogenous population of patients with recurrent PROC.
- |||||||||| batiraxcept (AVB-500) / Aravive
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer (clinicaltrials.gov) - Jan 17, 2024 P1, N=36, Not yet recruiting, However, in AXL high tumors, the PFS and OS were higher in participants who received batiraxcept with paclitaxel compared to paclitaxel alone. Trial completion date: Aug 2033 --> Nov 2033 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Aug 2028 --> Nov 2028
- |||||||||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Dec 27, 2023 P1/2, N=12, Active, not recruiting, Trial completion date: Aug 2033 --> Nov 2033 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Aug 2028 --> Nov 2028 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- |||||||||| batiraxcept (AVB-500) / Aravive
Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Monotherapy, Metastases: AVB500-RCC-003: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - Oct 30, 2023 P1b/2, N=72, Terminated, Trial completion date: Apr 2033 --> Aug 2033 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: May 2028 --> Aug 2028 Trial completion date: Mar 2025 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Aug 2023; Due to business reasons
- |||||||||| Bavencio (avelumab) / EMD Serono, batiraxcept (AVB-500) / Aravive
Trial primary completion date, Combination therapy, Metastases: COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov) - Oct 13, 2023 P1, N=19, Active, not recruiting, N=99 --> 34 | Trial completion date: Oct 2025 --> Aug 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Aug 2023; Due to business reasons Trial primary completion date: Aug 2023 --> Jan 2024
- |||||||||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Aug 18, 2023 P1/2, N=19, Active, not recruiting, Trial primary completion date: Aug 2023 --> Jan 2024 Trial completion date: Sep 2023 --> Feb 2024 | Trial primary completion date: Sep 2023 --> Feb 2024
- |||||||||| batiraxcept (AVB-500) / Aravive, Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Clinical, Combination therapy, Monotherapy, Metastases: Phase 2 Study of Batiraxcept (AVB-S6-500, an AXL inhibitor) as Monotherapy, in Combination With Cabozantinib (Cabo), and in Combination With Cabo and Nivolumab (Nivo) in Patients With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) @xingao04 #MGCCatASCO23 https://t.co/I4j2RKV3WG (Twitter) - Jun 3, 2023
- |||||||||| batiraxcept (AVB-500) / Aravive, Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Phase 2 study of batiraxcept (AVB-S6-500, an AXL inhibitor) as monotherapy, in combination with cabozantinib (cabo), and in combination with cabo and nivolumab (nivo) in patients with advanced clear cell renal cell carcinoma (ccRCC). (On Demand | Hall A; Poster Bd # 26) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2035; P1b/2 Batiraxcept-based combinations demonstrated efficacy and tolerability. Given encouraging safety and efficacy signals, batiraxcept + cabo will be further studied in a phase 3 trial of 2L+ ccRCC patients whose disease has progressed on prior IO and VEGF-TKI treatment.
- |||||||||| Bavencio (avelumab) / EMD Serono, batiraxcept (AVB-500) / Aravive
Trial primary completion date, Combination therapy, Metastases: COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov) - Apr 18, 2023 P1, N=19, Active, not recruiting, Given encouraging safety and efficacy signals, batiraxcept + cabo will be further studied in a phase 3 trial of 2L+ ccRCC patients whose disease has progressed on prior IO and VEGF-TKI treatment. Trial primary completion date: Apr 2022 --> Jul 2023
- |||||||||| batiraxcept (AVB-500) / Aravive
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: AVB500-RCC-003: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - Jan 18, 2023 P1b/2, N=80, Active, not recruiting, Trial completion date: Apr 2024 --> Oct 2025 | Trial primary completion date: Apr 2023 --> Oct 2024 Recruiting --> Active, not recruiting | Trial completion date: Jul 2023 --> Mar 2025 | Trial primary completion date: Dec 2022 --> Dec 2024
- |||||||||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Dec 9, 2022 P1/2, N=19, Active, not recruiting, Efficacy for the combination is encouraging compared to historical cabozantinib monotherapy data. Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Sep 2022 --> Sep 2023
- |||||||||| Bavencio (avelumab) / EMD Serono, batiraxcept (AVB-500) / Aravive
Enrollment closed, Trial completion date, Combination therapy, Metastases: COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov) - May 5, 2022 P1, N=19, Active, not recruiting, Our study provides strong pre-clinical rationale for combining AVB-500 with paclitaxel in aggressive endometrial cancer models. Recruiting --> Active, not recruiting | Trial completion date: Jul 2022 --> Apr 2023
- |||||||||| batiraxcept (AVB-500) / Aravive
Exposure-response analysis of batiraxcept and application to recommended phase 2 dose in platinum-resistant ovarian and clear cell renal cancers (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6686; P1, P1b/2, Consistent with emerging U.S. Food and Drug Administration guidance around a more thoughtful approach to dose selection in cancer (“Project Optimus”), E‑R analysis supported the identification of batiraxcept 15mg/kg as the RP2D in the PROC P1b study. Furthermore, PK/PD and preliminary activity of batiraxcept 15mg/kg+cabozantinib are consistent with these data and support the batiraxcept RP2D of 15mg/kg across different tumor types and combinations with batiraxcept.
- |||||||||| batiraxcept (AVB-500) / Aravive
Trial completion: Phase 1 Study of 3D229 in Healthy Subjects (clinicaltrials.gov) - Mar 2, 2022 P1, N=24, Completed, Given AXL’s role in glucose homeostasis, one or more glycolytic intermediates may prove to be a useful biomarker to help predict sensitivity in patients, thus tailoring who would benefit from this treatment combination. Active, not recruiting --> Completed
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