Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Batiraxcept

Paclitaxel is the standard of care, background therapy

Placebo

This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.

Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)

Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

Proportion of subjects who have a confirmed partial or complete response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

Subject QOL will be assessed using the Functional Assessment Of Cancer Therapy - Ovarian Cancer (FACT-O) questionnaire, which consists of 4 subscales: physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7 questions), and 12 additional concerns specific to ovarian cancer. All items are rated on a 5 point scale with 0 "not at all" and 4 "very much". The scoring algorithm allows for eight summary scales: the four core well-being subscales, a subtotal of the 27 core items, a subtotal of the 12 ovarian-specific additional concerns, a grand total of the 39 items, and a trial outcome index (sum of the 17 physical and functional wellbeing items plus the 12 ovarian-specific items).

Change from the baseline in GAS6 serum levels.

PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Aravive, Inc.

Uterine Neoplasms

Disease Attributes

Uterine Diseases

Patients will receive up to 9 21-day cycles of paclitaxel + AVB-500. Patients will receive AVB-500 via intravenous (IV) infusion at the assigned dose level on days 1, 8, and 15 of each cycle. Patients will receive IV paclitaxel at a dose of 175 mg/m\^2 on day 1 of each cycle. After 3 cycles, patients will be assessed for disease response. Patients who have progression will not continue on treatment. Patients who have a partial response or stable disease will continue on treatment for another 3 cycles of paclitaxel + AVB-500 at the assigned dose. Patients will be assessed for response again at the end of 6 cycles and may continue on treatment if they have partial response (PR) or stable disease (SD). Up to 9 cycles of treatment with paclitaxel + AVB-500 may be given. At the end of the 9 cycles, patients with a SD or PR can continue on maintenance AVB-500 until progression. Patients with complete response will continue single agent AVB-500 as maintenance therapy until progression.

David G Mutch, M.D.

Katherine Fuh, M.D., Ph.D.

Andrea R Hagemann, M.D.

Ian Hagemann, M.D.

Lindsay Kuroki, M.D.

L. Stewart Massad, M.D.

Carolyn McCourt, M.D.

Dineo Khabele, M.D.

Matthew A Powell, M.D.

Premal Thaker, M.D.

Maggie Mullen, M.D.

Esther Lu, Ph.D.

Carolyn Muller, M.D.

Kathleen Moore, M.D.

The purpose of this study is to determine safety and tolerability of AVB-500 when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer.

AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Phase I/IB of AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

-Defined as the proportion of subjects who have a partial or complete response to therapy

-Defined as the time from start of treatment to the first radiologically documented disease progression, or death, whichever comes first. The alive patients without radiologically documented disease progression are censored at the last follow-up.

-Defined as the time from start of treatment to death. The alive patients are censored at the last follow-up.

National Cancer Institute (NCI)

Washington University School of Medicine

Fallopian Tube Neoplasms

Fallopian Tube Diseases

Fallopian Tube Cancer

Antibodies

Durvalumab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antibodies, Monoclonal

Antineoplastic Agents, Immunological

Immunologic Factors

Patients receive batiraxcept IV over 60 minutes on days 1, 15, and 29 of cycle 0, and on days 1 and 15 of subsequent cycles. Beginning cycle 1, patients also receive durvalumab IV over 60 minutes on day 1. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive durvalumab IV over 60 minutes on days 1 and 22 of cycle 0 and on day 1 of subsequent cycles. Beginning cycle 1, patients also receive batiraxcept IV over 60 minutes on days 1 and 15. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Amir A Jazaeri

This trial studies the side effects and best dose of AVB-S6-500 when given together with durvalumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum therapy or has come back. Immunotherapy with AVB-S6-500 and durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To determine toxicity profile of the combination of batiraxcept (AVB-S6-500) and durvalumab therapy.

SECONDARY OBJECTIVES:

I. To estimate objective response rate to combination AVB-S6-500 and durvalumab therapy.

II. To estimate the median immune-related progression free survival (irPFS) as well as overall survival (OS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 after treatment with combination durvalumab and AVB-S6-500.

III. To investigate molecular and immunological changes associated with the combination of AVB-S6-500 and durvalumab; specifically to describe changes in T cell populations (including but not limited to CD3, CD8, CD4, FOXP3) and cell proliferation, as well as report changes in the proportion of macrophage phenotypes M1 and M2 (with phenotypic markers potentially including arginase1, CD11b, PDL-1, and CD206).

EXPLORATORY OBJECTIVES:

I. To evaluate blood and tissue based biomarkers for immune related adverse events and disease progression.

II. To investigate impact and possible sensitization of pretreatment with AVB-S6-500 monotherapy on subsequent combination of durvalumab and AVB-S6-500.

III. To evaluate for molecular and immunologic differences between pre-treatment with single agent AVB-S6-500 as compared to durvalumab.

OUTLINE: This is a phase I, dose-escalation of batiraxcept, followed by a phase II study. In Phase I, patients receive both batiraxcept (intravenously \[IV\] over 60 minutes on days 1 and 15) and durvalumab (IV over 60 minutes on day 1) every cycle.

In Phase II, patients are randomized to 1 of 2 arms.

ARM I: Patients receive batiraxcept IV over 60 minutes on days 1, 15, and 29 of cycle 0, and on days 1 and 15 of subsequent cycles. Beginning cycle 1, patients also receive durvalumab IV over 60 minutes on day 1. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive durvalumab IV over 60 minutes on days 1 and 22 of cycle 0 and on day 1 of subsequent cycles. Beginning cycle 1, patients also receive batiraxcept IV over 60 minutes on days 1 and 15. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 weeks for at least 90 days.

AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Randomized Phase I/II Study of AVB-S6-500 in Combination With Durvalumab (MEDI4736) in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

Safety will be monitored in the monotherapy phase and in the combination therapy phase. Will tabulate adverse events by grade, and relationship to study drug. Will estimate the proportion of subjects that discontinue treatment due to treatment-related adverse events with 90% confidence intervals. Will estimate the unacceptable toxicity rate with a 90% confidence interval.

Aravive Biologics Inc

AstraZeneca

M.D. Anderson Cancer Center

Kidney Diseases

Carcinoma, Renal Cell

Urologic Neoplasms

Kidney Neoplasms

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Nivolumab

Immune Checkpoint Inhibitors

Two dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.

One dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.

One dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.

One dose level of batiraxcept administered Q2W will be evaluated.

Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC

Cabozantinib (Cabo)

Nivolumab is standard of care in the first line treatment of ccRCC

This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of AVB-S6-500 in combination with cabozantinib, AVB-S6-500 in combination with cabozantinib and nivolumab and AVB-S6-500 monotherapy in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The phase 1b portion of the study is open label and patients with advanced ccRCC who had progressed on or after at least one prior line of treatment will receive AVB-S6-500 + cabozantinib. Two dose levels will be evaluated. The Phase 2 portion of the study is open-label 3-part study to evaluate efficacy and tolerability of AVB-S6-500 + cabozantinib, AVB-S6-500 + cabozantinib + nivolumab, and AVB-S6-500 alone.

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

A Phase 1b/2 Study Of AVB-S6-500 In Combination With Cabozantinib, AVB-S6-500 In Combination With Cabozantinib and Nivolumab, and AVB-S6-500 Monotherapy in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Safety and tolerability of AVB-S6-500 in combination with cabozantinib.

Measured by dose limiting toxicities experienced in Phase 1b

Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. ORR is proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib + nivolumab in Phase 2 Part B. ORR is proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Measured by objective response rate (ORR) in patients receiving AVB-S6-500 in Phase 2 Part C. ORR is proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 2 Part C. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.

Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 in Phase 2 Part C. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 2 Part C. PFS is the time from treatment until radiological disease progression or death.

Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 2 Part C. OS is the time from the start of the treatment until death.

Area under the AVB-S6-500 concentration-time curve.

Maximum observed AVB-S6-500 concentration.

Time of maximum observed AVB-S6-500 concentration.

Apparent terminal half-life of AVB-S6-500.

Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.

Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. OS is the time from the start of the treatment until death.

Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A, PFS is the time from treatment until radiological disease progression or death.

Measured by duration of response (DOR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.

Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

Measured by progression-free survival (PFS) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. PFS is the time from treatment until radiological disease progression or death.

Measured by overall survival (OS) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. OS is the time from the start of the treatment until death.

Safety and tolerability of AVB-S6-500 alone

Safety and tolerability of AVB-S6-500 in combination with cabozantinib and nivolumab

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Pancreatin

Antimetabolites

Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine

batiraxcept

Nab paclitaxel

This is a Phase 1b/2 study of batiraxcept (AVB-S6-500) designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive batiraxcept, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma

A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Measured by the number of patients with AEs in Phase 1b portion of the study.

Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study.

Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2.

Area under the batiraxcept concentration-time curve.

Maximum observed batiraxcept concentration.

Time of maximum observed batiraxcept concentration.

Apparent terminal half-life of batiraxcept.

Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

Measured from the date of partial or complete response to therapy until the cancer progresses.

Time following the treatment until death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer	NCT04729608	Platinum-resist...	Batiraxcept Paclitaxel Placebo	18 Years -	Aravive, Inc.
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer	NCT05826015	Recurrent High ...	Paclitaxel Batiraxcept	18 Years -	Washington University School of Medicine
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT04019288	Platinum-Resist... Platinum-Resist... Platinum-Resist... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Refractory Fall... Refractory Ovar... Refractory Prim...	Batiraxcept Durvalumab	18 Years -	M.D. Anderson Cancer Center
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma	NCT04300140	Clear Cell Rena...	Batiraxcept Cabozantinib (C... Nivolumab	18 Years -	Aravive, Inc.
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma	NCT04983407	Pancreatic Aden...	batiraxcept Nab paclitaxel Gemcitabine	18 Years -	Aravive, Inc.
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma	NCT04300140	Clear Cell Rena...	Batiraxcept Cabozantinib (C... Nivolumab	18 Years -	Aravive, Inc.

Spots Global Cancer Trial Database for batiraxcept

Every month we try and update this database with for batiraxcept cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for batiraxcept

Every month we try and update this database with for batiraxcept cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for batiraxcept cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.