About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
2. Histologically-confirmed epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC).
3. Platinum-resistant disease (progression ≥1 month and ≤6 months after a minimum of four cycles of last platinum-based treatment)
4. 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
5. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
6. Adequate organ and hematologic function
7. No more than four prior treatment regimens for platinum-resistant disease
8. 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

1. Platinum-refractory disease (defined as progression on or within 3 months of completing primary first-line platinum-based treatment)
2. Non-epithelial histology, including malignant mixed Mullerian tumors
3. Ovarian tumors with low malignant potential (i.e., borderline tumors), low grade serous ovarian cancer or carcinosarcoma
4. History of acute coronary syndromes.
5. History of or current Class II, III, or IV heart failure.
6. History or evidence of known central nervous system (CNS) metastases or carcinomatous meningitis.
7. Significant bleeding disorders, vasculitis or a significant bleeding episode from the Gastrointestinal (GI) tract.
8. History of severe hypersensitivity reactions to antibodies.
9. Systemic steroid therapy.
10. History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs.
11. Prior organ transplantation including allogenic or autologous stem cell transplantation
12. Prior treatment with anti-cluster of differentiation 47 (CD47) or anti-SIRPα therapy.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.