Study of TTI-622 in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multi-center, open-label study designed to evaluate TTI-622 administered in combination with Pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. Approximately 50 patients will be enrolled in the study (this includes two phases, the Dose Escalation and Dose Expansion).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trillium Therapeutics Inc.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

• Histologically-confirmed epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC).

• Platinum-resistant disease (progression ≥1 month and ≤6 months after a minimum of four cycles of last platinum-based treatment)

• Progression with standard of care therapies, including platinum-based therapies, poly ADP ribose polymerase (PARP) inhibitors or bevacizumab in the platinum-sensitive setting or intolerability to such therapies or patient refusal

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

• Adequate organ and hematologic function

• No more than four prior treatment regimens for platinum-resistant disease

• All adverse events from prior treatment must be the Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.

Key Exclusion Criteria:

• Platinum-refractory disease (defined as progression on or within 3 months of completing primary first-line platinum-based treatment)

• Non-epithelial histology, including malignant mixed Mullerian tumors

• Ovarian tumors with low malignant potential (i.e., borderline tumors), low grade serous ovarian cancer or carcinosarcoma

• History of acute coronary syndromes.

• History of or current Class II, III, or IV heart failure.

• History or evidence of known central nervous system (CNS) metastases or carcinomatous meningitis.

• Significant bleeding disorders, vasculitis or a significant bleeding episode from the Gastrointestinal (GI) tract.

• History of severe hypersensitivity reactions to antibodies.

• Systemic steroid therapy.

• History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs.

• Prior organ transplantation including allogenic or autologous stem cell transplantation

• Prior treatment with anti-cluster of differentiation 47 (CD47) or anti-SIRPα therapy.