Clinical Programs
The CRDF-004 phase 2 randomized trial for the 1st line treatment of patients with a RAS-mutated metastatic colorectal cancer (mCRC) is designed to generate preliminary safety and efficacy data, and confirm the optimal dose
*The full clinical data can be found in the corporate presentation.
Unmet Need in RAS-Mutated Metastatic Colorectal Cancer
Approximately 150,000 new cases of colorectal cancer are diagnosed annually in the United States, with roughly 20% of patients presenting with metastatic disease at diagnosis. RAS mutations are among the most common genetic alterations in mCRC, accounting for a substantial proportion of the metastatic patient population. Despite advances in cancer treatment, outcomes for these patients remain poor. When treated with current first-line standard-of-care regimens, patients with RAS-mutated mCRC experience a median progression-free survival of less than 12 months, and only approximately 15% survive five years following diagnosis. These outcomes underscore the urgent need for new therapeutic approaches capable of delivering more durable disease control and improved long-term survival.
CRDF-004 Phase 2 Trial Results
The randomized, controlled Phase 2 CRDF-004 trial is evaluating onvansertib, a first-in-class PLK1 inhibitor, in combination with standard-of-care regimens (FOLFIRI/bevacizumab or FOLFOX/bevacizumab) in patients with first-line RAS-mutated mCRC. Onvansertib 30 mg in combination with FOLFIRI/bevacizumab demonstrated deep and durable tumor shrinkage, with clinically meaningful improvements in overall response rate and progression-free survival compared with standard-of-care alone, without additive adverse events.
Based on these results, and following a successful End-of-Phase-2 meeting with the U.S. FDA, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial as a first-line treatment for patients with RAS-mutated mCRC.