This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.
At least 18 years of age
Patients must have epithelial ovarian, peritoneal, or fallopian tube cancer that is confirmed by histology or cytology, with a histopathological diagnosis of serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma.
Progression of disease within 6 months of last platinum-based chemotherapy, OR
Patients who have an intolerance for further platinum-based therapy.
Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.
Activated partial thromboplastin time (aPTT) >1.5 × ULN. Exception: Participants on therapeutic heparin may be allowed if aPTT is between 1.5 and 2.5 × ULN.
International Normalized Ratio (INR) >1.5. Exception: Participants on warfarin are allowed if INR is between 2.0 and 3.0 on two consecutive measurements taken 1-4 days apart.
Anticoagulant use: Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes is excluded. Prophylactic anticoagulation (e.g., low-molecular-weight heparin [LMWH] 40 mg/day) or use of anticoagulants for venous access device patency is permitted if the participant has been on a stable dose for ≥4 weeks without bleeding complications.
Roswell Park Cancer Institute
Lead sponsor
Generate Biomedicines
Collaborator