Study on Ivonescimab for Treating Endometrial and Cervical Cancers

Inclusion Criteria

• Have endometrial or cervical cancer that has spread or returned after treatment with at least one platinum-based chemotherapy.
  • For endometrial cancer, types can include endometrioid, serous, clear cell, and others.
  • For cervical cancer, types can include squamous cell carcinoma and adenocarcinoma.
• Have measurable cancer based on specific medical criteria.
• Be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have received at least one line of platinum-based therapy. Previous treatments with PD1 or VEGF therapies are allowed.
• Have controlled blood pressure, with or without medication, at or below 160/90 mmHg.
• Meet specific blood and organ function requirements, including:
  • Adequate blood cell counts and clotting ability.
  • Sufficient kidney function.
  • Liver function within specified limits.
  • Normal thyroid function or normal free T4 if TSH is abnormal.
• Be 18 years or older.
• If brain metastases were treated, they must be stable with no bleeding or large lesions.
• Not be pregnant or nursing, and use effective contraception if of childbearing potential.
• Have clinical data available or provide a tissue sample for analysis.
• Can have other cancers if they do not interfere with this study.

Exclusion Criteria

• Have had major surgery or serious injury within 4 weeks before starting the study or plan major surgery soon after starting.
• Have not fully recovered from previous surgery.
• Have a history of significant bleeding issues or are at risk of bleeding.
• Have had major heart problems or other serious health issues within the past year.
• Have untreated or unstable brain metastases.
• Have certain imaging findings that indicate advanced cancer spread.
• Have participated in another cancer study within 4 weeks before starting this one.
• Have a prolonged QT interval on an ECG.
• Have active hepatitis B or C infections.
• Have an allergy to the study drugs.
• Have had an organ transplant.
• Have an immune deficiency or are on immunosuppressive therapy.
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have a history of lung inflammation requiring steroids.
• Have had severe immune-related side effects from previous treatments.
• Have received a live vaccine within 30 days before starting the study.