TTI-621-01 (NCT02663518)

This study is currently recruiting patients. For more information, including a list of trial locations, please refer to clinicaltrials.gov.

TTI-621-01 (NCT02663518) is a multicenter, open-label phase 1a/b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and select solid tumors. This trial is being conducted in two phases. In the Dose Escalation phase (phase 1a), subjects with lymphoma were enrolled in sequential dose cohorts and received TTI-621 to characterize safety, tolerability, pharmacokinetics and the maximum tolerated dose (MTD). In the Expansion Phase (phase 1b), TTI-621 is being given as monotherapy to patients with advanced hematologic malignancies and select solid tumors to further define safety and to characterize efficacy. The specific cancers being studied are: Indolent B cell lymphoma, aggressive B cell lymphoma, T cell lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia, T and B cell acute lymphoblastic leukemia, myelodysplastic syndrome, myeloproliferative neoplasms and small cell lung cancer. The phase 1b will also assess the safety and efficacy of TTI-621 when it is given in combination with rituximab for patients with CD20-positive lymphoma and in combination with the PD-1 checkpoint inhibitor nivolumab in patients with Hodgkin lymphoma. In this study TTI-621 is given as a 1 hour intravenous infusion once per week.

Preliminary data from this study have been reported at the 2016 American Society of Hematology Annual Meeting and at the 2017 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Symposium. In phase 1a, a well-tolerated dose of 0.2 mg/kg/week was identified. The principal adverse events were manageable infusion reactions and transient thrombocytopenia, which is consistent with augmented systemic phagocytosis. Importantly, the transient decrease in platelets observed immediately following TTI-621 exposure was attenuated in most patients receiving multiple infusions. No drug-induced anemia was observed, consistent with prior results demonstrating that TTI-621 does not appreciably bind human red blood cells. Building on the observation of good overall tolerability, we amended the trial to allow dose intensification in 0.1 mg/kg increments to a maximum of 0.5 mg/kg. In the phase 1a we observed decreasing tumor volume and/or reduced metabolic activity over extended intervals of continued dosing in several patients and one patient achieved a partial response.

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