A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer

Launched by BIO-THERA SOLUTIONS · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BAT8006 for women with platinum-resistant ovarian cancer, which is a type of cancer that doesn't respond well to standard chemotherapy. The goal is to see how effective BAT8006 is in shrinking tumors and to check how safe it is for patients. The trial is not yet recruiting participants, but it aims to include women aged 18 and older who have a confirmed diagnosis of advanced or metastatic ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

To participate, women must be able to provide informed consent, meaning they understand the study and are willing to follow the procedures. They should have at least one measurable tumor and a life expectancy of at least three months. However, those who are pregnant, have had major surgery recently, or have certain medical conditions may not be eligible. Participants can expect to be closely monitored throughout the study to ensure their safety and to track how well the treatment is working. This trial is important because it could provide new options for patients facing limited treatment choices.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
• • 2. Women ≥ 18 years old.
• • 3. Subjects with histologically or cytologically confirmed platinum-resistant, advanced or metastatic epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
• • 4. Presence of at least one measurable lesion per RECIST v1.1. that was not in a prior radiation or other locally treated area.
• • 5. Life expectancy ≥ 3 months.
• • 6. Adequate hematological, liver, kidney and coagulation function.
• • Exclusion Criteria
• • 1. Females who are pregnant or nursing.
• • 2. Had major surgery within 28 days of the Screening visit.
• • 3. History of autologous transplantation ≤ 3 months
• • 4. History of severe infection deemed clinically significant by the PI or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study drug.
• • 5. History of human immunodeficiency virus (HIV) infection.
• • 6. Active hepatitis B or C.
• • 7. Any other serious underlying medical.
• • 8. Received cancer-directed therapy within the timeframes.
• • 9. Subjects have other active malignancies within 5 years prior to the first dose.
• • 10. Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
• • 11. Vaccinated with any live-attenuated vaccine within 4 weeks.
• • 12. Subjects with known history of psychiatric disorders, drug abuse, alcoholism or drug addiction.
• • 13. Subjects who are estimated by the investigator to have poor compliance with the clinical study or who have other factors that are not appropriate to participate in the study in the opinion of the investigator.