OncoMatch/Clinical Trials/NCT07790510
HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer
Is NCT07790510 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including HSK42360-Na Tablets and Cetuximab (EGFR inhibitor) for metastatic colorectal cancer (crc).
Treatment: HSK42360-Na Tablets · Cetuximab (EGFR inhibitor) · mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU) · FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF v600 mutation
Genetic testing documentation (limited to PCR or NGS-based assays) must be provided prior to enrollment to demonstrate BRAF V600 mutation positivity
Excluded: RAS mutation
Known RAS mutation
Excluded: MSH2 loss
Known MSI-H/dMMR or unknown MSI/MMR status
Excluded: MSH6 loss
Known MSI-H/dMMR or unknown MSI/MMR status
Excluded: MLH1 loss
Known MSI-H/dMMR or unknown MSI/MMR status
Excluded: PMS2 loss
Known MSI-H/dMMR or unknown MSI/MMR status
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: BRAF inhibitor (encorafenib, dabrafenib, vemurafenib)
Prior treatment with any BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib, etc.)
Cannot have received: EGFR inhibitor (cetuximab)
Prior treatment with any EGFR inhibitor (e.g., cetuximab, etc.)
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L; hemoglobin ≥90 g/L (no transfusion or growth factor support within 7 days prior to testing)
Kidney function
Serum creatinine ≤1.5×ULN, or creatinine clearance ≥50 mL/min (measured or calculated using the Cockcroft-Gault equation)
Liver function
Total serum bilirubin ≤1.5×ULN; AST and/or ALT ≤2.0×ULN; if liver metastases are present, or if Gilbert syndrome is clearly documented, AST and/or ALT ≤3.0×ULN, total bilirubin ≤1.5×ULN
Cardiac function
QTcF ≤450 msec for males or ≤470 msec for females; LVEF ≥50%; no myocardial infarction, unstable angina, NYHA Class III or IV heart failure within 6 months prior to first dose
Laboratory values meeting the following standards: ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L; hemoglobin ≥90 g/L (no transfusion or growth factor support within 7 days prior to testing); Total serum bilirubin ≤1.5×ULN; AST and/or ALT ≤2.0×ULN; if liver metastases are present, or if Gilbert syndrome (unconjugated hyperbilirubinemia) is clearly documented, AST and/or ALT ≤3.0×ULN, total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or creatinine clearance ≥50 mL/min (measured or calculated using the Cockcroft-Gault equation); Coagulation: INR and APTT ≤1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07790510 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BRAF inhibitor, EGFR inhibitor disqualifies patients from enrollment.
Does this trial require BRAF?
Yes, BRAF v600 mutation is a required biomarker for enrollment.
Are patients with RAS alterations eligible?
No. RAS mutation is an exclusion criterion.
Are patients with MSH2 alterations eligible?
No. MSH2 loss is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages