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

NCT07790510 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • Metastatic Colorectal Cancer (CRC)

Interventions

DRUG

HSK42360-Na Tablets

HSK42360-Na tablets administered orally once, twice, or three times daily depending on the assigned dose level, in 28-day treatment cycles.

DRUG

Cetuximab (EGFR inhibitor)

Cetuximab 500 mg/m2 administered by intravenous infusion every 2 weeks.

DRUG

mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU)

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.

DRUG

FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU)

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-12
Primary Completion
2029-09-30
Completion
2030-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790510 on ClinicalTrials.gov