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NCT07790510 · ClinicalTrials.gov record · last posted 2026-08-27

HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer

Name: HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer — clinical trial record (NCT07790510)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1/2

SponsorHaisco Pharmaceutical Group Co., Ltd.

Started2026-08-12

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Trial Details

NCT Number	NCT07790510
Lead Sponsor	Haisco Pharmaceutical Group Co., Ltd.
Conditions	Metastatic Colorectal Cancer (CRC)
Enrollment	180 participants
Start Date	2026-08-12
Primary Completion	2029-09-30 (estimated)
Study Completion	2030-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-27