On January 30, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the first patient has been dosed in its Phase 1/2 clinical trial of CFT1946, an orally bioavailable mutant-selective BiDAC degrader for the treatment of BRAF V600 mutant solid tumors (Press release, C4 Therapeutics, JAN 30, 2023, View Source [SID1234626634]).

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"Dosing the first patient in the CFT1946 Phase 1/2 clinical trial marks the first degrader to enter clinical development to target BRAF-driven cancers. Many of these patients are typically treated with BRAF inhibitors and have few treatment options once resistance emerges," said Adam Crystal, M.D., Ph.D., chief medical officer of C4 Therapeutics. "Preclinically, in in vivo models, CFT1946 has demonstrated deeper and more durable activity than approved BRAF inhibitors, and promising activity in the setting of resistance to BRAF inhibitors. We look forward to advancing CFT1946 for patients with BRAF V600 mutant cancers including non-small cell lung cancer, colorectal cancer, and melanoma."

The Phase 1/2 clinical trial will primarily investigate safety, tolerability, and anti-tumor activity, with secondary and exploratory objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT1946. The initial arm of the Phase 1 portion of the study will evaluate CFT1946 as a single agent in patients with BRAF V600 mutant solid tumors. As the Phase 1 trial progresses, an additional arm of the trial will evaluate CFT1946 in combination with trametinib, also in patients with BRAF V600 mutant solid tumors. Following the identification of the recommended dose(s), the Phase 2 portion of the trial is expected to expand to three investigational arms to evaluate: (1) CFT1946 monotherapy in patients with V600 mutant melanoma or non-small cell lung cancer (NSCLC) after prior BRAF inhibitor treatment; (2) CFT1946 in combination with trametinib in patients with V600 mutant melanoma or NSCLC after prior BRAF inhibitor treatment; and (3) CFT1946 in combination with trametinib in patients with V600 mutant NSCLC who have not previously been treated with a BRAF inhibitor.

CFT1946 is C4T’s third oncology program to enter clinical studies from its proprietary TORPEDO platform.