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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Platinum-resistant Ovarian Cancer

Intervention / Treatment
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* Drug: Batiraxcept
* Drug: Paclitaxel
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible. Aged 18 years or older Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1 Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance. Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy. Received at least 1 but not more than 4 prior therapy regimens. Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy. Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access. Measurable disease according to RECIST v1.1 criteria Normal gastrointestinal function. At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept. Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia. Exclusion Criteria: Tumors in the breast or bone Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization. Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen) Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer. Received prior therapy with PAC in the platinum-resistant recurrent setting Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of batiraxcept/placebo

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Batiraxcept+PAC<br>Combination of batiraxcept and PAC | Drug: Batiraxcept<br>* Batiraxcept is an experimental drug<br>* Other names: AVB-S6-500;Drug: Paclitaxel<br>* Paclitaxel is the standard of care, background therapy<br>* Other names: Taxol;|
| Placebo Comparator: Placebo+PAC<br>Placebo-controlled arm with PAC | Drug: Paclitaxel<br>* Paclitaxel is the standard of care, background therapy<br>* Other names: Taxol;Other: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC | PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time following the treatment until death | 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, Platinum resistant, Recurrent ovarian cancer, High-grade serous adenocarcinoma