BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer

Launched by BIOMIMETIX JV, LLC · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with advanced ovarian or endometrial cancer that has come back after previous treatments. The researchers are testing a drug called BMX-001, which is combined with a common chemotherapy drug called paclitaxel (PTX). The goal is to see if this new combination can help fight the cancer more effectively while also reducing some of the painful side effects, especially nerve damage caused by chemotherapy, which can greatly affect a patient’s quality of life.

To be eligible for the trial, participants must be at least 18 years old and have advanced cancer that has worsened despite previous treatments. They should be able to understand the study and give their consent. Patients will have regular check-ups to monitor their health, and the researchers will assess how well the treatment works and if it is safe. This trial is an important step in finding better treatments for women facing these challenging cancers, and if successful, it may lead to improved options for many patients in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Recurrent advanced metastatic ovarian or endometrial cancer that progressed during or following prior SOC therapy
• • 2. Aged 18 years or older
• • 3. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
• • 4. Ability to understand and willingness to give written informed consent
• • 5. Measurable disease according to RECIST v1.1 or assessable disease based on presence of malignancy pleural effusion or ascites, or disease that does not meet measurable criteria.
• • 6. Negative serum pregnancy test within 48 hours of dosing if indicated.
• • 7. Adequate bone marrow function
• • 8. Adequate hepatic function
• • 9. Adequate renal function as determined by calculated or measured creatinine clearance ≥30 mL/min (using Cockcroft- Gault equation) or serum creatinine \< 1.5 X institutional ULN
• • 10. Full recovery from all recent surgery on start date of treatment; at least 1 week must have elapsed from the time of a minor surgery (port placement at any time is acceptable); from the date of treatment at least 21 days must have elapsed from the time of a major surgery. Must have fully recovered from all surgery-related toxicities to Grade 1 or less
• • 11. At least 28 days between termination of prior anticancer or hormonal therapy and first administration of BMX-001
• Exclusion Criteria:
• • 1. Residual Grade 2 peripheral neuropathy
• • 2. Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy), Subjects requiring corticosteroid therapy for the management of CNS metastases may not be on \>10 mg/day prednisone or equivalent. Subjects that have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to enrollment.
• • 3. Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying cancer
• • 4. Subjects who have received prior therapy with weekly PTX in the recurrent setting.
• • 5. Clinically significant cardiac disease.
• • 6. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (eg, uncontrolled seizures)
• • 7. Nonhealing wound, ulcer, or bone fracture
• • 8. Serious active infection requiring IV antibiotics and/or hospitalization within 7 days of enrollment
• • 9. 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)
• • 10. Require regular blood transfusions, platelet transfusions, or granulocyte colony stimulating factor.
• 11. For female patients of childbearing potential, the following are exclusion criteria, as applicable:
• • 12. Refusal to use highly effective method of contraception or to practice true abstinence during treatment and for 6 months after the last dose of study drug
• • 13. Pregnant or breast feeding;
• • 14. Presence of any other condition that may increase the risk associated with enrollment on the study, interfere with data interpretation, or make the patient inappropriate for study enrollment in the opinion of the treating investigator
• • 15. Prior treatment with or participation in a study with BMX-001
• • 16. A history of additional risk factors for Torsades de Pointes (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome).
• • 17. Severe, active co-morbidity, as defined in protocol.