Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether HSK42360-Na tablets can be given with cetuximab, an EGFR-targeting drug, with or without standard chemotherapy, in metastatic colorectal cancers carrying a BRAF V600 mutation. The early part of the trial will find a tolerable dose; later groups will look for early signs of tumour control as well as safety.
The idea is that adding HSK42360-Na to cetuximab, alone or with mFOLFOX6 or FOLFIRI chemotherapy, might control BRAF V600-mutant cancer better than cetuximab-based treatment alone. In this trial, the main test is whether the combination can be given safely, measured chiefly by dose-limiting toxicities; tumour response and how long the cancer stays controlled are secondary questions.
Worth knowing: This is an open-label, single-arm early-phase trial with no comparison group, so it is mainly testing safety and dose rather than showing that the treatment helps people live longer.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07790510 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 180 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Haisco Pharmaceutical Group Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug HSK42360-Na Tablets
- Drug Cetuximab (EGFR inhibitor)
- Drug mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU)
- Drug FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU)
What it is measuring
dose-limiting toxicities (DLTs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- BRAF V600E
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Age ≥18 years; voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form;
2. ECOG performance status 0-1;
3. Estimated survival time >3 months;
4. Histologically or cytologically confirmed metastatic and unresectable colorectal adenocarcinoma. For Phase I, Phase II Cohort 1, and the safety lead-in period of Cohorts 2/3: previously received one or more systemic treatments for metastatic colorectal cancer, and failed standard treatment, or have no standard treatment option, or standard treatment is not applicable at this stage; for the subsequent expansion phase of Phase II Cohorts 2/3: no prior systemic treatment for metastatic colorectal cancer;
5. Genetic testing documentation (limited to PCR or NGS-based assays) must be provided prior to enrollment to demonstrate BRAF V600 mutation positivity;
6. Agree to provide tumor tissue and/or blood samples;
7. At least one measurable lesion according to RECIST 1.1 criteria;
8.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07790510, registered by Haisco Pharmaceutical Group Co., Ltd. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.