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Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3beta) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors
The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.
Primary: Parts 1 and 2: To evaluate the safety and tolerability, describe any dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or highest protocol-defined doses (in the absence of exceeding the MTD) and the recommended Phase 2 study dose (RP2D) for 9-ING-41 as monotherapy (Study Part 1) and in combination with chemotherapies (Study Part 2) in patients with relapsed or refractory malignancies. Part 3: To assess clinical benefit in patients with relapsed or refractory malignancies treated with 9-ING-41-based combinations at the RP2D established in Part 2. Secondary: 1. To assess pharmacokinetics and pharmacodynamics of 9-ING-41 2. To correlate response rates with specific molecular tumor profile(s) in a descriptive fashion
9-ING-41 (); Adriamycin (doxorubicin); CPT-11 (irinotecan); Camptosar (irinotecan); Gemzar (gemcitabine); Lomustine (CeeNU); Nab-paclitaxel (Abraxane); Paraplatin (carboplatin); Taxol (paclitaxel); carboplatin (); doxorubicin (); gemcitabine (); irinotecan (); paclitaxel ()