Ovarian Cancer Clinical Trial
Study of TTI-622 in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer
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).
Pegylated liposomal doxorubicin (PLD) is a standard treatment option for patients with platinum-resistant ovarian cancer who are not candidates for chemotherapy in combination with bevacizumab. However, despite being consider a standard treatment option, the clinical benefit of chemotherapy for this patient population is small. The goal of this clinical trial is to improve upon the activity of PLD in a safe manner to provide a more effective therapeutic option for this group of patients.
TTI-622-02 is a multi-center, open-label study designed to evaluate TTI-622 administered in combination with PLD in patients with platinum-resistant ovarian cancer and for whom PLD is a reasonable treatment option. The first portion of the study will evaluate the safety of increasing dose levels of TTI-622 in combination with PLD at 40 mg/m2 in patients with platinum-resistant EOC, including ovarian, peritoneal and fallopian tube malignancy, and establish a combination regimen for further evaluation in a dose expansion cohort. The study will consist of a 28-day screening period, a treatment period in which patients will receive TTI-622 in combination with PLD in 28-day cycles until documentation of objective disease progression or development of unacceptable toxicity, and a long-term follow-up period to assess overall survival.
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.
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There are 10 Locations for this study
Santa Monica California, 90403, United States
Orlando Florida, 32806, United States
Orlando Florida, 32806, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Mayfield Heights Ohio, 44124, United States
Tulsa Oklahoma, 74146, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77024, United States
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