RecruitingPhase I/IIEN originalColorectal cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat i dobra ogólna kondycja zdrowotna
  • •Potwierdzony zaawansowany rak jelita grubego, który nie może być operacyjnie usunięty
  • •Potwierdzona mutacja genetyczna BRAF V600 (wymagany test genetyczny)
  • •Co najmniej jeden widoczny guz, który można zmierzyć
  • •Zadowalające wyniki badań krwi i funkcji wątroby oraz nerek
  • •Kobiety w wieku rozrodczym muszą mieć ujemny test ciąży

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 27, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Beijing Cancer Hospital

Beijing, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/28/2026.

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