TL32711
TL32711 is being investigated in Phase 1 clinical trials as a single agent and in combination with five different standard-of-care chemotherapies. Summaries of the Phase 1 studies are provided below.
TL32711 is entering Phase 2 clinical studies in solid tumors as a single agent and in combination with standard-of-care chemotherapies, as well as a Phase 1/2 study in acute myeloid leukemia. As part of the clinical program, TetraLogic has an ongoing biomarker program to identify patients most likely to respond to TL32711.
Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of TL32711 when administered as a 30 minute intravenous infusion once weekly for three weeks per repeated 4 week intervals in subjects with refractory solid tumors or lymphoma. Anti-tumor activity, pharmacokinetics, and exploratory biomarkers as a measurement of pharmacodynamic effects will also be assessed.
Phase 1b/2a five-arm combination dose-escalation study of TL32711 in subjects with advanced or metastatic solid tumors. Combinations include TL32711 with carboplatin/paclitaxel, irinotecan, docetaxel, gemcitabine and liposomal doxorubicin.
Phase 1/2 open-label, non-randomized dose escalation study of TL32711 in patients ≥60 years of age with AML who have relapsed disease or who are newly diagnosed and not candidates for standard induction therapy.
More information about TetraLogic's ongoing clinical trials can be found at www.clinicaltrials.gov