2021-01-19 07:03:46 CCCC C4 Therapeutics
01/19/21 01/1907:03 01/19/2107:03 | C4 Therapeutics announces FDA clearance for CFT7455 IND applicationC4 Therapeutics announced that the U.S. Food and Drug Administration has cleared the company's investigational new drug application for its lead product candidate, CFT7455, an orally bioavailable MonoDAC targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma. The FDA has completed its 30-day safety review and granted approval for the company to proceed with the proposed Phase 1/2 clinical trial for CFT7455. The Phase 1/2 clinical trial will be an open-label, two-part dose-escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies. The Phase 1 portion of the trial will explore CFT7455 as a single agent in patients with relapsed or refractory multiple myeloma and non-Hodgkin lymphomas, and in parallel in combination with dexamethasone in R/R MM patients. Following the identification of an optimal dose, the Phase 2 expansion portion of the trial will enroll additional investigational arms including patients with MM, as single agent and in combination with dexamethasone, and as single agent in patients with mantle cell lymphoma and peripheral T-cell lymphoma, two subtypes of NHL. The trial will primarily investigate safety and tolerability, with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti-tumor activity of CFT7455. |
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