HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer
A Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in Patients With BRAF V600-Mutant Metastatic Colorectal Cancer
Haisco Pharmaceutical Group Co., Ltd.
180 participants
Aug 12, 2026
INTERVENTIONAL
Conditions
Summary
This is a Phase I/II, single-arm, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HSK42360-Na tablets combined with cetuximab with or without chemotherapy in patients with BRAF V600-mutant metastatic colorectal cancer (mCRC). The Phase I stage uses a 3+3 dose escalation design to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of HSK42360-Na in combination with cetuximab. The Phase II stage evaluates the efficacy and safety of HSK42360-Na combined with cetuximab alone or with mFOLFOX6/FOLFIRI chemotherapy in expansion cohorts.
Eligibility
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Interventions
HSK42360-Na tablets administered orally once, twice, or three times daily depending on the assigned dose level, in 28-day treatment cycles.
Cetuximab 500 mg/m2 administered by intravenous infusion every 2 weeks.
Oxaliplatin 85 mg/m2 IV over 2 hours (Day 1), Leucovorin 400 mg/m2 IV over 2 hours (Day 1), 5-FU 400 mg/m2 IV bolus (Day 1) followed by 1200 mg/m2/day continuous IV infusion over 46-48 hours (total 2400 mg/m2), repeated every 2 weeks.
Irinotecan 180 mg/m2 IV over 30-90 minutes (Day 1), Leucovorin 400 mg/m2 IV over 2 hours (Day 1), 5-FU 400 mg/m2 IV bolus (Day 1) followed by 1200 mg/m2/day continuous IV infusion over 46-48 hours (total 2400 mg/m2), repeated every 2 weeks.
Locations(1)
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NCT07790510