Metastatic Colorectal Cancer (CRC)Phase 1/2NCT07790510
HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer
A Phase 1/2 study testing HSK42360-Na Tablets, Cetuximab (EGFR inhibitor) and mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU) in people with Metastatic Colorectal Cancer (CRC), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- HSK42360-Na Tablets, Cetuximab (EGFR inhibitor) and mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2026to 30 Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years; voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form;
- ECOG performance status 0-1;
- Estimated survival time >3 months;
- 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;
- Genetic testing documentation (limited to PCR or NGS-based assays) must be provided prior to enrollment to demonstrate BRAF V600 mutation positivity;
- Agree to provide tumor tissue and/or blood samples;
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- At least one measurable lesion according to RECIST 1.1 criteria;
- Laboratory values meeting the following standards:
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelets (PLT) ≥100×10⁹/L; hemoglobin (HB) ≥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 (Scr) ≤1.5×ULN, or creatinine clearance ≥50 mL/min (measured or calculated using the Cockcroft-Gault equation); Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Men and women of childbearing potential must agree to use appropriate contraceptive methods (hormonal, barrier method, or abstinence) during the study and for 3 months after the last dose; women of childbearing potential must have a negative pregnancy test within 7 days prior to dosing; male participants must not donate sperm from the start of treatment until 90 days after stopping treatment;
- Fully understand this clinical trial and voluntarily sign the written informed consent form.
Who cannot join
- History of other malignancies within the past 2 years (excluding skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, and other low-grade malignancies that have undergone radical treatment);
- Known RAS mutation;
- Known MSI-H/dMMR or unknown MSI/MMR status; if the participant has dMMR/MSI-H mCRC and is unable to receive immune checkpoint inhibitors due to existing medical conditions, enrollment is permitted (only for the subsequent expansion phase of Cohorts 2 and 3);
- Prior treatment with any BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib, etc.) or any EGFR inhibitor (e.g., cetuximab, etc.) prior to screening;
- History of acute or chronic pancreatitis within 6 months prior to the start of study treatment, or history of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months prior to the start of study treatment;
- Impaired liver function, Child-Pugh Class B or C;
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- Uncontrolled (including but not limited to requiring repeated drainage, symptomatic) moderate or larger pleural effusion, pericardial effusion, or ascites, as determined by the investigator;
- Known symptomatic central nervous system metastasis or leptomeningeal metastasis, or other evidence indicating that the individual's CNS metastasis or leptomeningeal metastasis is not controlled, and the investigator judges that the patient is unsuitable for enrollment;
- Individuals receiving long-term immunosuppressive therapy (e.g., cyclosporine) or requiring daily systemic corticosteroid therapy (e.g., >20 mg prednisone or equivalent), excluding those using topical corticosteroids via nasal spray, inhalation, or other local routes;
- Systemic chemotherapy within 28 days prior to first dose, or immunotherapy (e.g., interleukin, interferon, thymosin, etc.), hormonal therapy, targeted therapy, or any investigational intervention within 14 days or 5 half-lives prior to first dose, whichever is shorter;
- Toxicity from prior antineoplastic therapy that has not resolved to CTCAE Grade ≤1 (excluding alopecia, skin toxicity, or other toxicities that the investigator considers to have no safety risk);
- Any condition affecting drug swallowing and severely affecting absorption of the study drug or pharmacokinetic parameters, including but not limited to active peptic ulcer disease, chronic gastroesophageal reflux disease (GERD), etc.;
- Severe or uncontrolled cardiac disease requiring treatment, including any of the following (but not limited to): QT interval prolongation on ECG corrected using Fridericia's formula, QTcF >450 msec for males or >470 msec for females; various clinically significant arrhythmias, including but not limited to ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; echocardiogram indicating left ventricular ejection fraction (LVEF) <50%; myocardial infarction, unstable angina, NYHA Class III or IV heart failure within 6 months prior to first dose;
- Arterial/venous thromboembolic events within 6 months prior to first dose, with uncontrolled risk as judged, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; or known familial and/or acquired thrombophilia, such as inherited or acquired deficiencies of anticoagulant proteins, coagulation factors, fibrinolytic proteins, etc.;
- Severe or uncontrolled diabetes, hypertension (poorly controlled despite standard antihypertensive regimen, with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening), active bleeding, epilepsy (except when caused by intracranial tumor), chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson's disease, etc.;
- Receipt of live vaccine within 28 days prior to first dose;
- Any unstable systemic disease (such as severe hepatic, renal, or metabolic diseases: cirrhosis, renal failure, uremia, etc.);
- Use of strong or moderate CYP3A4 inhibitors or inducers, or foods, within 14 days or 5 half-lives prior to first dose, whichever is longer. Use of CYP3A4, CYP2C9, and CYP2C8 sensitive substrates, OATP1B1, OATP1B3, OAT1, OAT3, P-gp, and BCRP substrates within 5 half-lives prior to first dose (see Appendix 7 for details);
- Cognitive impairment, unstable moderate to severe psychiatric illness, other uncontrolled concomitant diseases, alcohol dependence, steroid dependence, or drug abuse;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; major surgery or severe trauma within 4 weeks prior to first dose (excluding needle biopsy performed for sample collection); or planned systemic or local tumor resection during the study;
- History of immunodeficiency, including: HIV antibody positive, or other acquired or congenital immunodeficiency diseases;
- Presence of the following serological status reflecting active hepatitis B or hepatitis C infection:
- Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV DNA >1000 copies/mL or HBV DNA >200 IU/mL; Hepatitis C virus antibody positive, and HCV RNA > upper limit of normal;
- Active syphilis infection;
- History of tuberculosis treatment within 2 years prior to first dose;
- Active bacterial, fungal, or viral infection prior to first dose (defined as requiring intravenous antibacterial, antifungal, or antiviral drug treatment). Individuals receiving prophylactic anti-infective treatment without clinical manifestations of active infection prior to first dose may be considered for enrollment;
- Known allergy to or contraindication for any component of the study drug or its excipients at the planned dose;
- Positive pregnancy test at screening, or lactating patients;
- The investigator considers the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
lin shen, 0086-10-88196561, doctorshenlin@sina.cn
About this study
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in Patients With BRAF V600-Mutant Metastatic Colorectal Cancer
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.
Read the detailed description
This is a prospective, multi-center, single-arm, open-label Phase I/II clinical study. The study consists of two stages:
Phase I (Dose Escalation): A 3+3 dose escalation design with 3 pre-specified dose levels of HSK42360-Na tablets (1200 mg QD, 1200 mg BID, 1200 mg TID) in combination with cetuximab (500 mg/m2 IV every 2 weeks). Each dose level enrolls 3-6 evaluable participants. A 28-day cycle comprises the DLT observation period. Backfill cohorts of approximately 6-18 participants per dose level may be enrolled after safety confirmation. The primary objectives are to evaluate safety, tolerability, and determine the DLT, MTD, and RP2D.
Phase II (Cohort Expansion): After RP2D determination, three expansion cohorts are planned:
- Cohort 1: HSK42360-Na + cetuximab (approximately 42 participants with prior systemic therapy)
- Cohort 2: HSK42360-Na + cetuximab + mFOLFOX6 (6-9 safety run-in + approximately 36 expansion)
- Cohort 3: HSK42360-Na + cetuximab + FOLFIRI (6-9 safety run-in + approximately 36 expansion)
Participants continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other termination criteria. Tumor assessment is performed every 6 weeks (every 8 weeks after 18 months) per RECIST 1.1. Safety follow-up occurs 30 days after the last dose, and survival follow-up is conducted every 3 months thereafter.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- HSK42360-Na Tablets, Cetuximab (EGFR inhibitor), mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU), FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK42360-Na TabletsDrug
HSK42360-Na tablets administered orally once, twice, or three times daily depending on the assigned dose level, in 28-day treatment cycles.
Cetuximab (EGFR inhibitor)Drug
Cetuximab 500 mg/m2 administered by intravenous infusion every 2 weeks.
mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU)Drug
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.
FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Escalation | Experimental | Not described Receives: Drug: HSK42360-Na Tablets; Drug: Cetuximab (EGFR inhibitor) |
| Phase II Cohort Expansion | Experimental | Not described Receives: Drug: HSK42360-Na Tablets; Drug: Cetuximab (EGFR inhibitor); Drug: mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU); Drug: FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs) during the first 28-day treatment cycle.
Measured: during the first 28-day treatment cycle.
Maximum tolerated dose (MTD)
Measured: Up to approximately 8 months
recommended Phase II dose (RP2D)
Measured: Up to approximately 8 months
Secondary outcomes (10)
Tmax
Measured: Up to approximately 36 months
Objective response rate (ORR)
Measured: Up to approximately 36 months
Progression-free survival (PFS)
Measured: Up to approximately 36 months
Overall survival (OS)
Measured: Up to approximately 36 months
Duration of response (DOR)
Measured: Up to approximately 36 months
Disease control rate (DCR)
Measured: Up to approximately 36 months
Cmax
Measured: Up to approximately 36 months
AUC0-t
Measured: Up to approximately 36 months
AUC0-∞
Measured: Up to approximately 36 months
t1/2
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start12 Aug 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790510
- Sponsor's protocol ID
- HSK42360-Na-T1-201
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in Patients With BRAF V600-Mutant Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07790510
- Acronym / sponsor ID
- HSK42360-Na-T1-201
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multi-center, single-arm, open-label Phase I/II clinical study. The study consists of two stages:
Phase I (Dose Escalation): A 3+3 dose escalation design with 3 pre-specified dose levels of HSK42360-Na tablets (1200 mg QD, 1200 mg BID, 1200 mg TID) in combination with cetuximab (500 mg/m2 IV every 2 weeks). Each dose level enrolls 3-6 evaluable participants. A 28-day cycle comprises the DLT observation period. Backfill cohorts of approximately 6-18 participants per dose level may be enrolled after safety confirmation. The primary objectives are to evaluate safety, tolerability, and determine the DLT, MTD, and RP2D.
Phase II (Cohort Expansion): After RP2D determination, three expansion cohorts are planned:
- Cohort 1: HSK42360-Na + cetuximab (approximately 42 participants with prior systemic therapy)
- Cohort 2: HSK42360-Na + cetuximab + mFOLFOX6 (6-9 safety run-in + approximately 36 expansion)
- Cohort 3: HSK42360-Na + cetuximab + FOLFIRI (6-9 safety run-in + approximately 36 expansion)
Participants continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other termination criteria. Tumor assessment is performed every 6 weeks (every 8 weeks after 18 months) per RECIST 1.1. Safety follow-up occurs 30 days after the last dose, and survival follow-up is conducted every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation | Experimental | Drug: HSK42360-Na Tablets, Drug: Cetuximab (EGFR inhibitor) |
| Phase II Cohort Expansion | Experimental | Drug: HSK42360-Na Tablets, Drug: Cetuximab (EGFR inhibitor), Drug: mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU), Drug: FOLFIRI Regimen (Irinotecan/Leucovorin/5-FU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years; voluntarily participate in this clinical trial, understand the study procedures, and have signed the informed consent form;
- ECOG performance status 0-1;
- Estimated survival time >3 months;
- 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;
- Genetic testing documentation (limited to PCR or NGS-based assays) must be provided prior to enrollment to demonstrate BRAF V600 mutation positivity;
Key exclusion criteria (29 listed)
- History of other malignancies within the past 2 years (excluding skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, and other low-grade malignancies that have undergone radical treatment);
- Known RAS mutation;
- Known MSI-H/dMMR or unknown MSI/MMR status; if the participant has dMMR/MSI-H mCRC and is unable to receive immune checkpoint inhibitors due to existing medical conditions, enrollment is permitted (only for the subsequent expansion phase of Cohorts 2 and 3);
- Prior treatment with any BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib, etc.) or any EGFR inhibitor (e.g., cetuximab, etc.) prior to screening;
- History of acute or chronic pancreatitis within 6 months prior to the start of study treatment, or history of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months prior to the start of study treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK42360-Na TabletsHSK42360-Na tablets administered orally once, twice, or three times daily depending on the assigned dose level, in 28-day treatment cycles. | Drug | Phase I Dose Escalation, Phase II Cohort Expansion |
| Cetuximab (EGFR inhibitor)Cetuximab 500 mg/m2 administered by intravenous infusion every 2 weeks. | Drug | Phase I Dose Escalation, Phase II Cohort Expansion |
| 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 | Phase II Cohort Expansion |
| 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. | Drug | Phase II Cohort Expansion |
Primary outcome
dose-limiting toxicities (DLTs)
Time frame: during the first 28-day treatment cycle.
Incidence and severity of dose-limiting toxicities (DLTs) during the first 28-day treatment cycle.
Maximum tolerated dose (MTD)
Time frame: Up to approximately 8 months
recommended Phase II dose (RP2D)
Time frame: Up to approximately 8 months
10 secondary outcomes
Tmax
Time frame: Up to approximately 36 months
Objective response rate (ORR)
Time frame: Up to approximately 36 months
Progression-free survival (PFS)
Time frame: Up to approximately 36 months
Overall survival (OS)
Time frame: Up to approximately 36 months
Duration of response (DOR)
Time frame: Up to approximately 36 months
Disease control rate (DCR)
Time frame: Up to approximately 36 months
Cmax
Time frame: Up to approximately 36 months
AUC0-t
Time frame: Up to approximately 36 months
AUC0-∞
Time frame: Up to approximately 36 months
t1/2
Time frame: Up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HSK42360-Na Tablets, Cetuximab (EGFR inhibitor) and mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU) in people with Metastatic Colorectal Cancer (CRC), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lin shen (0086-10-88196561, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicities (DLTs) (time frame: during the first 28-day treatment cycle.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.