Platinum-Resistant Recurrent Ovarian Cancer MedDRA version: 21.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Batiraxcept
Product Code: AVB-S6-500
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Batiraxcept
CAS Number: 2268717-61-7
Current Sponsor code: AVB-S6-500
Other
Sponsors
Aravive, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible. 2. Aged 18 years or older 3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 4. Ability to understand the nature of this clinical study and willingness to give written informed consent, comply with scheduled visits, the treatment plan, laboratory tests, and follow up visits 5. 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. 6. Available archived tumor tissue (a paraffin-embedded tissue block with sufficient tumor tissue for biomarker testing or unstained slides with sufficient tumor tissue may be substituted) or if archived tissue is not available, a fresh tumor biopsy is required. 7. Radiologic imaging with a computerized tomography (CT) scan or magnetic resonance imaging (MRI) (if cannot tolerate a CT scan) within 21 days of randomization. (If a site can document the CT performed as part of the positron emission tomography [PET]-CT is of identical diagnostic quality to a diagnostic CT [with IV and oral contrast], then the CT portion of a PET-CT can be used.) 8. Received at least 1 but not more than 4 prior therapy regimens since ovarian cancer diagnosis. a. Maintenance therapy OR hormonal therapies should not be counted as a separate therapy. b. 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. 9. Ovarian cancer that is measurable according to RECIST v1.1 10. Normal gastrointestinal (GI) function. (e.g., no grade = 2 diarrhea, constipation, nausea, vomiting, or abdominal pain at the time of randomization per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Patients with a partial or full bowel obstruction within 3 months of randomization are not eligible. 11. Life expectancy >3 months 12. Negative serum pregnancy test within 7 days prior to randomization for females of childbearing potential (premenopausal and not surgically sterilized). 13. Adequate bone marrow function: a. Absolute neutrophil count =1500/µL b. Platelet count =100,000/ µL c. Hemoglobin =9.0 g/dL Transfusion and growth factor support are allowed if they were given = 14 days prior to randomization 14. Adequate hepatic function: a. Total bilirubin =1.5×upper limit of normal (ULN) b. Aspartate aminotransferase (AST) =3.0×ULN* c. Alanine aminotransferase (ALT) =3.0×ULN* *Unless liver metastases are present, in which case AST/ALT must be =5×ULN 15. Adequate renal function as determined by calculated or measured creatinine clearance = 30 mL/min (using Cockcroft-Gault equation). 16. International normalized ratio (INR) =1.5 and activated partial thromboplastin time (aPTT) =1.5 ULN for subjects not on anticoagulation treatment. If subjects are on anticoagulation treatment, the corresponding laboratory values should be in therapeutic range for the respective agent. 17. Full recovery from all recent surgery on date of randomization; at least 1 week must have elapsed from the time of a minor
Exclusion criteria
Exclusion criteria: 1. Tumors in the breast or bone 2. Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy). 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. 3. Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen) 4. Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer. 5. Received prior therapy with PAC in the platinum-resistant recurrent setting 6. Clinically significant cardiac disease history including the following: a. cardiac arrhythmia uncontrolled on medication b. unstable angina or clinically and/or electrocardiographically documented myocardial infarction within 6 months before randomization c. clinically significant valvular disease d. uncontrolled congestive heart failure e. clinically significant pericardial effusion. 7. History of a prior malignancy that was active (not indolent) within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, endometrial stage 1 cancer, or carcinoma in situ of the cervix or breast 8. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (eg, uncontrolled seizures) 9. Nonhealing wound, ulcer, or bone fracture 10. 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. 11. Serious active infection requiring IV antibiotics and/or hospitalization within 7 days of randomization. 12. Known severe hypersensitivity to any of the study drugs or excipients, including history of allergic, anaphylactic, or other severe hypersensitivity reactions to fusion proteins, products containing Cremophor EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate), or known hypersensitivity or allergy to Chinese hamster ovary cell products. Patients with prior non-severe hypersensitivity to paclitaxel administration may be enrolled if documented that they were subsequently able to tolerate paclitaxel administration and are deemed suitable for paclitaxel treatment by the investigator. 13. History of or evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the subject’s participation for the full duration of the Study Treatment, affect subject compliance, place the subject at high risk from treatment-related complications, confound the results of the study, or is not in the best interest of the subject to participate. 14. Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, or any other known active viral illness such as coronavirus disease 2019 (COVID-19). 15. Patient currently breastfeeding or intending to become pregnant on study or within 6 months following discontinuation of Study Treatment. 16. Ever participated in a study with batiraxcept
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of AVB-S6-500 plus Paclitaxel (PAC) (AVB-S6-500 + PAC) versus Placebo and PAC (Placebo + PAC) on progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, in subjects with platinum-resistant recurrent ovarian cancer.;Secondary Objective: To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on overall survival (OS) ;Primary end point(s): PFS based on investigator-assessed RECIST v1.1 criteria;Timepoint(s) of evaluation of this end point: During all study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OS Exploratory analyses include the following additional assessments: - ORR based on investigator-assessed RECIST v1.1 - DOR based on investigator-assessed RECIST v1.1 - Quality of life (QOL) as assessed by the FACT-O score - CBR based on investigator-assessed RECIST v1.1 - Multiple PK endpoints, including Cycle 1 Day 15 trough level - CA-125 per Gynecologic Cancer Intergroup guidelines - Expression/activity of AXL pathway biomarkers (e.g., AXL, sAXL, and GAS6) Efficacy endpoints in biomarker-defined subgroups will be based on expression/activation of these biomarkers in serum. Safety endpoints: - Adverse events by system organ class and preferred terms using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 - Clinical laboratory results (serum chemistry, hematology etc.) - Vital signs (blood pressure, heart rate, body temperature etc.) - 12-lead electrocardiogram measurements - Physical examination - Pregnancy test results Immunogenicity endpoint: - Anti-drug antibodies to batiraxcept ;Timepoint(s) of evaluation of this end point: During all study duration | — |
Countries
Belgium, Canada, Czechia, Czech Republic, France, Georgia, Germany, Greece, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public Contactclinical department
InnoPharma srl
Outcome results
None listed