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- batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Phase Ib study of AVB-S6-500 (axl inhibition) in combination with durvalumab (MEDI4736) in patients with platinum-resistant, recurrent epithelial ovarian cancer (NCT04019288) (TBD) - Jan 26, 2022 - Abstract #SGO2022SGO_210;
P1/2
2. Describe the efficacy of AVB-S6-500 in combination with Durvalumab and factors that may have impacted it
- batiraxcept (AVB-500) / Aravive
GAS6-AXL inhibition by AVB-500 overcomes resistance to paclitaxel in endometrial cancer by decreasing tumor cell glycolysis (TBD) - Jan 26, 2022 - Abstract #SGO2022SGO_111;
Understand the mechanism by which AVB-500 + paclitaxel compromises the tumor cell's ability to undergo glycolysis 2. Understand the relationship between GAS6 and AXL expression in endometrial cancer tumors and chemo-response.
- || batiraxcept (AVB-500) / Aravive, Avastin (bevacizumab) / Roche
P1 data, Journal, Combination therapy: Phase 1b study of AVB-500 in combination with paclitaxel or pegylated liposomal doxorubicin platinum-resistant recurrent ovarian cancer. (Pubmed Central) - Jan 7, 2022
P1b/2
AVB-500 was well-tolerated in combination with PAC or PLD and contributed to the clinical activity of PAC in PROC patients. Subgroup analyses identified a population of PROC patients who may benefit the most from AVB-500 treatment, which will be further assessed in an ongoing Phase 3 PROC trial.
- ||| batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Enrollment change, 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 23, 2021
P1/2, N=19, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Subgroup analyses identified a population of PROC patients who may benefit the most from AVB-500 treatment, which will be further assessed in an ongoing Phase 3 PROC trial. N=39 --> 19 | Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
- || Avastin (bevacizumab) / Roche
Clinical, Journal: Inhibition of AXL and VEGF-A Has Improved Therapeutic Efficacy in Uterine Serous Cancer. (Pubmed Central) - Dec 13, 2021
In addition, intraperitoneal mouse models demonstrated a significant decrease in tumor burden in two cell lines. The combination of AVB-500 and bevacizumab reduced tumor burden in vivo and reduced morphogenesis and migration in vitro which are vital to the process of angiogenesis.
- || batiraxcept (AVB-500) / Aravive
Enrollment closed: Phase 1 Study of 3D229 in Healthy Subjects (clinicaltrials.gov) - Dec 1, 2021
P1, N=24, Active, not recruiting, Sponsor: 3D Medicines
The combination of AVB-500 and bevacizumab reduced tumor burden in vivo and reduced morphogenesis and migration in vitro which are vital to the process of angiogenesis. Recruiting --> Active, not recruiting
- || batiraxcept (AVB-500) / Aravive, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Batiraxcept plus cabozantinib shows promise in kidney cancer https://t.co/ea2V1kfO41 #urology #urologist #kcsm #kidneycancer (Twitter) - Nov 22, 2021
- |||| batiraxcept (AVB-500) / Aravive, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
@AraviveInc announces positive preliminary data from the phase 1b trial evaluating batiraxcept (AVB-500) in combination w/ cabozantinib for treatment of clear cell #RCC. #ReadNow details on UroToday > https://t.co/0bNMlrpwHw #PressRelease @EJonasch @sitcancer #SITC21 (Twitter) - Nov 12, 2021
- Bavencio (avelumab) / EMD Serono, batiraxcept (AVB-500) / Aravive
Phase classification, Combination therapy, Metastases: COAXIN: Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov) - Oct 20, 2021
P1, N=24, Recruiting, Sponsor: University of Oklahoma
Recruiting --> Active, not recruiting Phase classification: P2 --> P1
- batiraxcept (AVB-500) / Aravive, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment () - Oct 12, 2021 - Abstract #KCRS2021KCRS_54;
Key eligibility criteria: ≥ 18 years, histologically confirmed metastatic ccRCC, and progression after 1st line therapy. Enrollment began December 2020.
- batiraxcept (AVB-500) / Aravive, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_958;
P1b/2
In mouse ccRCC xenograft models, AVB-500 showed significantly more tumor reduction in combination with pazopanib versus pazopanib alone...Safety, PK/PD and clinical activity will be updated at the time of presentation. (NCT04300140)
- | batiraxcept (AVB-500) / Aravive
Enrollment change, Trial withdrawal: Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy (clinicaltrials.gov) - Sep 29, 2021
P1, N=0, Withdrawn, Sponsor: Washington University School of Medicine
(NCT04300140) N=30 --> 0 | Not yet recruiting --> Withdrawn
- || batiraxcept (AVB-500) / Aravive
Trial primary completion date, Combination therapy: AVB500-OC-002: Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov) - Sep 27, 2021
P1b/2, N=53, Active, not recruiting, Sponsor: Aravive, Inc.
N=30 --> 0 | Not yet recruiting --> Withdrawn Trial primary completion date: Dec 2021 --> Jan 2021
- |||| batiraxcept (AVB-500) / Aravive, paclitaxel / Generic mfg.
Combination therapy: Great work by @Fuh_Lab. Get your access to this agent @GOG NCT04729608 (weekly paclitaxel +/-AVB-500). Phase 1b study of AVB-500 in combination with paclitaxel or pegylated ... https://t.co/XqhC3DkBJp. (Twitter) - Sep 7, 2021
P3
- | 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) - Sep 5, 2021
P2, N=31, Recruiting, Sponsor: University of Oklahoma
Trial primary completion date: Dec 2021 --> Jan 2021 Trial primary completion date: Jul 2021 --> Jul 2022
- batiraxcept (AVB-500) / Aravive
[VIRTUAL] INHIBITION OF CANCER CELL-DEPENDENT GLYCOLYSIS THROUGH AVB-500, A SELECTIVE INHIBITOR OF GAS6-AXL, IN COMBINATION WITH PACLITAXEL IN HIGH-GRADE ENDOMETRIAL CANCER () - Aug 26, 2021 - Abstract #IGCS2021IGCS_496;
We show that this therapeutic combination decreases basal glycolysis through reduced PI3K/AKT signaling. This provides a metabolic mechanism for increasing uterine cancer sensitivity to chemotherapy.
- || batiraxcept (AVB-500) / Aravive
Enrollment open: Phase 1 Study of 3D229 in Healthy Subjects (clinicaltrials.gov) - Aug 19, 2021
P1, N=24, Recruiting, Sponsor: 3D Medicines
This provides a metabolic mechanism for increasing uterine cancer sensitivity to chemotherapy. Not yet recruiting --> Recruiting
- ||| batiraxcept (AVB-500) / Aravive
Enrollment open, Metastases: AVB500-PC-005: Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov) - Aug 4, 2021
P1b/2, N=80, Recruiting, Sponsor: Aravive, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || batiraxcept (AVB-500) / Aravive
New P1 trial: Phase 1 Study of 3D229 in Healthy Subjects (clinicaltrials.gov) - Jun 28, 2021
P1, N=24, Not yet recruiting, Sponsor: 3D Medicines
- | batiraxcept (AVB-500) / Aravive, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, 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 25, 2021
P1/2, N=39, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || AVB-500 / Aravive
P1 data, PK/PD data, Journal: Target-mediated drug disposition pharmacokinetic/pharmacodynamic model-informed dose selection for the first-in-human study of AVB-S6-500. (Pubmed Central) - Jun 16, 2021
Predicted GAS6 suppression duration of 14 days was accurate for the 1 mg/kg dose. A PK/PD model expedited clinical development of AVB-S6-500, minimized exposure of cancer patients to subtherapeutic doses, and rationally guided the optimal dosing in patients.
- AVB-500 / Aravive, Avastin (bevacizumab) / Roche
[VIRTUAL] A phase 3, randomized, double-blind, adaptive, placebo/paclitaxel-controlled study of AVB-S6-500 in combination with paclitaxel in patients with platinum-resistant recurrent ovarian cancer (GOG-3059/ENGOT OV-66/AVB500-OC-004). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2219;
P3
Simulations confirm a nominal one-sided type 1 error below 0.025, and show >90% statistical power for PFS under the following assumptions of PFS medians . Study recruitment began in Q1.
- AVB-500 / Aravive, Avastin (bevacizumab) / Roche
[VIRTUAL] Phase 1b study of GAS6/AXL inhibitor (AVB-500) in recurrent, platinum-resistant ovarian carcinoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2182;
P1b/2
AVB-500 was well-tolerated in combination with Pac or PLD . This Ph1b trial suggested a higher ORR in the Pac treated subgroup, with C1D15 trough levels > 13.8mg/L (most consistently achieved at the 15mg/kg dose level) .
- ||||| AVB-500 / Aravive, WuXi AppTec
Clinical: The GAS6/AXL inhibitor AVB-500, when combined with paclitaxel, elicited clinical benefit with favorable tolerability in patients with platinum-resistant ovarian cancer, according to data from a phase 1b study. @Fuh_Lab @WashU_OBGYN @SGO_org #SGOmtg #gyncsm https://t.co/NugUlVvUyg (Twitter) - Mar 28, 2021
- |||| AVB-500 / Aravive, WuXi AppTec
Clinical: AVB-500 Demonstrates Clinical Benefit in Platinum-Resistant Ovarian Cancer @Fuh_Lab @WashU_OBGYN @SGO_org #SGO2021 #gyncsm https://t.co/8dOsM2OzFg (Twitter) - Mar 23, 2021
- ||| AVB-500 / Aravive, WuXi AppTec
GAS6/AXL経路を阻害するAXLデコイ蛋白AVB-500が白金系抗癌薬に抵抗性の再発卵巣がんの治療薬になる可能性が報告されました。 #卵巣がん #GAS6 #SGOMtg https://t.co/UVDu1pKs9o (Twitter) - Mar 22, 2021
- ||||| AVB-500 / Aravive, WuXi AppTec
P1 data: Congrats @Fuh_Lab from @WashU_OBGYN! Outstanding presentation of results from a Phase I study of GAS6/AXL inhibitor (AVB-500) in recurrent platinum-resistant ovarian cancer. Supports further development! #SGOMtg #gyncsm (Twitter) - Mar 19, 2021
- |||||| batiraxcept (AVB-500) / Aravive
Enrollment open, Combination therapy: ENGOT OV66: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov) - Mar 9, 2021
P3, N=500, Recruiting, Sponsor: Aravive, Inc.
This Ph1b trial suggested a higher ORR in the Pac treated subgroup, with C1D15 trough levels > 13.8mg/L (most consistently achieved at the 15mg/kg dose level) . Not yet recruiting --> Recruiting
- AVB-500 / Aravive, WuXi AppTec
[VIRTUAL] GAS6 inhibition induces platinum sensitivity through increased replication stress in ovarian cancer () - Jan 29, 2021 - Abstract #SGO2021SGO_850;
Inhibition of the GAS6 pathway with AVB improves sensitivity of platinum-resistant cells to platinum chemotherapy by increasing replication stress and DNA damage and decreasing HR. GAS6 is a potential biomarker predictive of poor response to platinum-based neoadjuvant chemotherapy and might identify patients who would benefit from treatment with AVB.
- AVB-500 / Aravive, WuXi AppTec, Imfinzi (durvalumab) / AstraZeneca
[VIRTUAL] Phase I/II study of AVB-S6-500 in combination with durvalumab (MEDI4736) in patients with platinum-resistant, recurrent epithelial ovarian cancer () - Jan 29, 2021 - Abstract #SGO2021SGO_697;
- AVB-500 / Aravive, WuXi AppTec, Avastin (bevacizumab) / Roche
[VIRTUAL] Phase I study of GAS6/AXL inhibitor (AVB-500) in recurrent, platinum-resistant ovarian carcinoma () - Jan 29, 2021 - Abstract #SGO2021SGO_623;
AVB-500was found to be safe and tolerable in this Ph1B trial in combination with Paclitaxel or PLD. The RP2D was based upon PK/PD parameters.
- AVB-500 / Aravive, WuXi AppTec
[VIRTUAL] Inducing homologous recombination deficiency using AVB500, a receptor tyrosine kinase AXL inhibitor in uterine serous cancer (USC) () - Jan 29, 2021 - Abstract #SGO2021SGO_468;
- AVB-500 / Aravive, WuXi AppTec, Lynparza (olaparib) / Merck (MSD), AstraZeneca
[VIRTUAL] AVB-500, a receptor tyrosine kinase AXL inhibitor, in combination with olaparib improves response in uterine serous cancer () - Jan 29, 2021 - Abstract #SGO2021SGO_467;
- AVB-500 / Aravive, WuXi AppTec
[VIRTUAL] AVB-500, a selective inhibitor of GAS6-AXL, in combination with paclitaxel alters uterine serous cancer cell metabolism () - Jan 29, 2021 - Abstract #SGO2021SGO_61;
- AVB-500 / Aravive, WuXi AppTec
[VIRTUAL] AVB-500, a selective inhibitor of GAS6-AXL, shows improved therapeutic efficacy in combination with paclitaxel in uterine serous carcinoma () - Jan 29, 2021 - Abstract #SGO2021SGO_60;
- |||||||||| batiraxcept (AVB-500) / Aravive
New P3 trial, Combination therapy: ENGOT OV66: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov) - Jan 27, 2021
P3, N=500, Not yet recruiting, Sponsor: Aravive, Inc.
- | batiraxcept (AVB-500) / Aravive
Trial completion date, Trial primary completion date: Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy (clinicaltrials.gov) - Jan 20, 2021
P1, N=30, Not yet recruiting, Sponsor: Washington University School of Medicine
The RP2D was based upon PK/PD parameters. Trial completion date: Feb 2028 --> Aug 2029 | Trial primary completion date: Feb 2023 --> Aug 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) - Jan 15, 2021
P1/2, N=36, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Feb 2028 --> Aug 2029 | Trial primary completion date: Feb 2023 --> Aug 2024 Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Sep 2021
- ||| batiraxcept (AVB-500) / Aravive
Enrollment open, 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) - Dec 8, 2020
P1b/2, N=63, Recruiting, Sponsor: Aravive, Inc.
Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Sep 2021 Not yet recruiting --> Recruiting
- ||| batiraxcept (AVB-500) / Aravive
Enrollment change, Trial 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 22, 2020
P1b/2, N=63, Not yet recruiting, Sponsor: Aravive, Inc.
Not yet recruiting --> Recruiting N=108 --> 63 | Trial completion date: Mar 2023 --> Jul 2023
- ||| batiraxcept (AVB-500) / Aravive
Enrollment closed, Enrollment change, Combination therapy: AVB500-OC-002: Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer (clinicaltrials.gov) - Oct 7, 2020
P1b/2, N=53, Active, not recruiting, Sponsor: Aravive, Inc.
N=108 --> 63 | Trial completion date: Mar 2023 --> Jul 2023 Recruiting --> Active, not recruiting | N=196 --> 53
- | batiraxcept (AVB-500) / Aravive
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy (clinicaltrials.gov) - Sep 28, 2020
P2a, N=1, Terminated, Sponsor: Aravive, Inc.
Recruiting --> Active, not recruiting | N=196 --> 53 N=24 --> 1 | Trial completion date: Mar 2021 --> Aug 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Aug 2020; Business reasons
- | batiraxcept (AVB-500) / Aravive
Trial completion date, Trial primary completion date: Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy (clinicaltrials.gov) - Jul 27, 2020
P1, N=30, Not yet recruiting, Sponsor: Washington University School of Medicine
N=24 --> 1 | Trial completion date: Mar 2021 --> Aug 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Aug 2020; Business reasons Trial completion date: Aug 2027 --> Feb 2028 | Trial primary completion date: Aug 2022 --> Feb 2023
- || batiraxcept (AVB-500) / Aravive
Trial initiation 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) - Jul 23, 2020
P1b/2, N=108, Not yet recruiting, Sponsor: Aravive, Inc.
Trial completion date: Aug 2027 --> Feb 2028 | Trial primary completion date: Aug 2022 --> Feb 2023 Initiation date: Mar 2020 --> Oct 2020
- AVB-500 / Aravive, WuXi AppTec, Lynparza (olaparib) / Merck (MSD), AstraZeneca
[VIRTUAL] Effect of inducing HR deficiency using AVB500, a receptor tyrosine kinase AXL inhibitor, on response to olaparib in uterine serous cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_4625;
AVB500 appears to induce HR deficiency. Additional therapeutic and mechanistic experiments are ongoing.
- AVB-500 / Aravive, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Improving response to olaparib in uterine serous cancer through treatment with AVB500, a receptor tyrosine kinase AXL inhibitor (Metro Toronto Convention Centre - Hall E) - Mar 19, 2020 - Abstract #SGO2020SGO_2578;
AVB500 in combination with olaparib demonstrates an improved response over olaparib alone with a greater decrease in tumor burden through increasing DNA damage. Additional therapeutic and mechanistic experiments with primary USC cancer cells developed from metastatic USC patients are ongoing.
- paclitaxel / Generic mfg.
Inducing 'BRCAness' by inhibiting the GAS6/AXL pathway in high-grade serous ovarian cancer (Metro Toronto Convention Centre - Hall E) - Mar 19, 2020 - Abstract #SGO2020SGO_2385;
Inhibition of this GAS6/AXL pathway with AVB induces BRCAness in sporadic HGSC, which leads to an improved sensitivity to carboplatin and olaparib. In addition, high levels of GAS6 can identify patients who have worse response to platinum-based chemotherapy and may benefit from this novel GAS6/AXL inhibitor.
- AVB-500 / Aravive, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Improving response to olaparib in uterine serous cancer through treatment with AVB500, a receptor tyrosine kinase AXL inhibitor (Metro Toronto Convention Centre - Hall E) - Mar 19, 2020 - Abstract #SGO2020SGO_1946;
AVB500 in combination with olaparib demonstrates an improved response over olaparib alone with a greater decrease in tumor burden through increasing DNA damage. Additional therapeutic and mechanistic experiments with primary USC cancer cells developed from metastatic USC patients are ongoing.
- paclitaxel / Generic mfg.
Inducing 'BRCAness' by inhibiting the GAS6/AXL pathway in high-grade serous ovarian cancer (Metro Toronto Convention Centre - Hall E) - Mar 19, 2020 - Abstract #SGO2020SGO_1753;
Inhibition of this GAS6/AXL pathway with AVB induces BRCAness in sporadic HGSC, which leads to an improved sensitivity to carboplatin and olaparib. In addition, high levels of GAS6 can identify patients who have worse response to platinum-based chemotherapy and may benefit from this novel GAS6/AXL inhibitor.
- AVB-500 / Aravive, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Improving response to olaparib in uterine serous cancer through treatment with AVB500, a receptor tyrosine kinase AXL inhibitor (Metro Toronto Convention Centre - Hall E) - Mar 19, 2020 - Abstract #SGO2020SGO_1289;
AVB500 in combination with olaparib demonstrates an improved response over olaparib alone with a greater decrease in tumor burden through increasing DNA damage. Additional therapeutic and mechanistic experiments with primary USC cancer cells developed from metastatic USC patients are ongoing.