Colorectal Cancer (CRC)Phase 1/2NCT07683403
Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal Cancer
A Phase 1/2 study testing Savolitinib plus cetuximab and FOLFOX chemotherapy and Cetuximab and FOLFOX chemotherapy in people with Colorectal Cancer (CRC), run by Fudan University at 5 sites in China.
Trial summary
The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Savolitinib plus cetuximab and FOLFOX chemotherapy and Cetuximab and FOLFOX chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jun 2026to 30 Jun 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form after fully understanding this study;
- Aged 18 to 75 years (inclusive), male or female;
- Have at least one measurable lesion (RECIST 1.1);
- Histologically confirmed unresectable locally advanced or metastatic colorectal cancer;
- pMMR by immunohistochemistry or unknown MMR protein expression status;
- KRAS/NRAS and BRAF all wild-type;
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- c-MET IHC intensity score 2+ or 3+ in ≥50% of tumor cells in the primary lesion; or positive by FISH; or NGS copy number ≥3;
- No prior systemic therapy (Note: prior neoadjuvant or adjuvant chemotherapy is allowed if disease progression/recurrence occurred during or ≥6 months after completion of such therapy);
- ECOG performance status 0-1;
- Life expectancy ≥12 weeks;
- Laboratory parameters (within 14 days without blood transfusion):
- Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥9 g/dL;
- Liver function: AST and ALT ≤2.5×ULN, total bilirubin ≤1.5×ULN; if liver metastases present, AST and ALT ≤5×ULN;
- Renal function: serum creatinine ≤1.5×ULN, creatinine clearance (CCr) ≥60 mL/min;
- Fertile male or female patients voluntarily agree to use effective contraceptive methods during the study and for 6 months after the last dose of study treatment.
Who cannot join
- Prior treatment with anti-EGFR monoclonal antibody therapy;
- Prior treatment with c-MET small molecule inhibitors or monoclonal antibodies targeting c-MET or HGF;
- Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment;
- Participated in another clinical trial of a drug not yet approved or marketed in China and received the investigational drug within 4 weeks prior to enrollment;
- Underwent any surgery or invasive treatment or procedure (except venous catheterization, puncture drainage, etc.) within 4 weeks prior to enrollment;
- INR >1.5 or APTT >1.5×ULN;
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- Clinically significant electrolyte abnormalities as judged by the investigator;
- Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
- Poorly controlled blood glucose (FBG ≥10 mmol/L);
- Any disease or condition affecting drug absorption, or inability to take oral savolitinib;
- Active gastric or duodenal ulcer, ulcerative colitis, or other gastrointestinal diseases, or active bleeding from an unresected tumor, or other conditions that may cause gastrointestinal bleeding or perforation within 28 days prior to enrollment;
- History or evidence of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (>5 mL fresh blood within 4 weeks), or thromboembolic events within 12 months;
- Clinically significant cardiovascular disease (e.g., acute myocardial infarction within 6 months, unstable angina, heart failure NYHA class >2, ventricular arrhythmia requiring medication, LVEF <50%);
- Other malignancy within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix);
- Active or uncontrolled serious infection:
- Known HIV infection;
- Known clinically significant liver disease, including active HBV infection (HBV DNA >1×10⁴ copies/mL or >2000 IU/mL);
- Known HCV infection with positive HCV RNA (>1×10³ copies/mL), or other hepatitis, liver cirrhosis;
- Known brain metastases (except adequately treated, inactive, asymptomatic lesions with no steroid use for at least 30 days);
- History of allergic reaction to compounds with similar chemical or biological composition to savolitinib;
- Persistent toxicity from prior anti-tumor therapy not recovered to ≤ Grade 2 (except alopecia and lymphopenia of any grade);
- Pregnant or breastfeeding women;
- Received blood transfusion, blood products, or hematopoietic factors (e.g., albumin, G-CSF) within 14 days prior to enrollment;
- Any clinical or laboratory abnormality or other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Changhai Hospital
Shanghai, 200000
Wei Zhang, Phd, 021-31166666, weizhang2000cn@163.com
Fudan University Shanghai Cancer Center
Shanghai, 200000
Ye Xu, Phd, 021-64175590, yexu@shmu.edu.cn
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, 200000
Zizhen Zhang, Phd, 021-58752345, zhangzizhen@renji.com
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, 200000
Tao Zhang, Phd, 021-64370045, zhangtao@ruijin.com
Zhongshan Hospital, Fudan University
Shanghai, 200000
Jianmin Xu, Phd, 021-64041990, xujmin@yahoo.com.cn
About this study
Official title: Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study
The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are:
Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone?
Read more
What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX?
Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes.
Participants will:
Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy
Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests
Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression
Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Savolitinib plus cetuximab and FOLFOX chemotherapy, Cetuximab and FOLFOX chemotherapy
- Keywords
- savolitinib, Colorectal cancer, cetuximab, c-MET
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savolitinib plus cetuximab and FOLFOX chemotherapyDrug
Savolitinib dosing regimen: 200mg, qd, po.
Cetuximab: Administered intravenously at an initial dose of 400 mg/m² prior to chemotherapy, followed by a weekly dose of 250 mg/m² infused over 1 hour.
FOLFOX chemotherapy regimen: Oxaliplatin 85 mg/m² intravenously over 2 hours on Day 1; leucovorin (LV) 400 mg/m² intravenously over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus on Day 1, followed by continuous intravenous infusion of 1200 mg/(m²·day) for 2 days (total dose 2400 mg/m², infused over 46-48 hours).
Cetuximab and FOLFOX chemotherapyDrug
Cetuximab: Administered intravenously at an initial dose of 400 mg/m² prior to chemotherapy, followed by a weekly dose of 250 mg/m² infused over 1 hour.
FOLFOX chemotherapy regimen: Oxaliplatin 85 mg/m² intravenously over 2 hours on Day 1; leucovorin (LV) 400 mg/m² intravenously over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus on Day 1, followed by continuous intravenous infusion of 1200 mg/(m²·day) for 2 days (total dose 2400 mg/m², infused over 46-48 hours).
| Study group | Role | What they receive |
|---|---|---|
| Savolitinib plus cetuximab and FOLFOX chemotherapy | Experimental | Not described Receives: Drug: Savolitinib plus cetuximab and FOLFOX chemotherapy |
| Cetuximab plus FOLFOX chemotherapy | Active comparator | Not described Receives: Drug: Cetuximab and FOLFOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The incidence of confirmed complete response or partial response
Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Secondary outcomes (6)
Progression free survival (PFS)
A duration from the date of initial treatment to disease progression or death of any cause. PFS was set as a key secondary outcome.
Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Disease control rate (DCR)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Duration of response (DOR)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Measured: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Time to response (TTR)
A duration from the date of initial treatment to the first time reported partial response.
Measured: From date of first dose of study drug until partial response (up to approximately 12 months)
Overall survival (OS)
Duration from the date of initial treatment to the date of death due to any cause
Measured: From date of first dose of study drug until withdrawal of consent or death (up to approximately 24 months)
Number and Proportion of patients with treatment-related adverse events as assessed by CTCAE v6.0
Use descriptive statistical analysis to record the number and proportion of patients who experience treatment-related adverse events out of all patients receiving the study drug. The grading of adverse events follows the CTCAE V6.0.
Measured: From the date of first dose of study drug to 90 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, multicenter, open-label study
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683403
- Sponsor's protocol ID
- HMPL-504-SUMMER-C101
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study
- ClinicalTrials.gov ID
- NCT07683403
- Acronym / sponsor ID
- HMPL-504-SUMMER-C101
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- savolitinib, Colorectal cancer, cetuximab, c-MET
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 6 Jul 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.
The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are:
Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone?
What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX?
Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes.
Participants will:
Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy
Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests
Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression
Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, multicenter, open-label study
| Arm | Type | Receives |
|---|---|---|
| Savolitinib plus cetuximab and FOLFOX chemotherapy | Experimental | Drug: Savolitinib plus cetuximab and FOLFOX chemotherapy |
| Cetuximab plus FOLFOX chemotherapy | Active comparator | Drug: Cetuximab and FOLFOX chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntarily sign the informed consent form after fully understanding this study;
- Aged 18 to 75 years (inclusive), male or female;
- Have at least one measurable lesion (RECIST 1.1);
- Histologically confirmed unresectable locally advanced or metastatic colorectal cancer;
- pMMR by immunohistochemistry or unknown MMR protein expression status;
Key exclusion criteria (24 listed)
- Prior treatment with anti-EGFR monoclonal antibody therapy;
- Prior treatment with c-MET small molecule inhibitors or monoclonal antibodies targeting c-MET or HGF;
- Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment;
- Participated in another clinical trial of a drug not yet approved or marketed in China and received the investigational drug within 4 weeks prior to enrollment;
- Underwent any surgery or invasive treatment or procedure (except venous catheterization, puncture drainage, etc.) within 4 weeks prior to enrollment;
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 |
|---|---|---|
| Savolitinib plus cetuximab and FOLFOX chemotherapySavolitinib dosing regimen: 200mg, qd, po. Cetuximab: Administered intravenously at an initial dose of 400 mg/m² prior to chemotherapy, followed by a weekly dose of 250 mg/m² infused over 1 hour. FOLFOX chemotherapy regimen: Oxaliplatin 85 mg/m² intravenously over 2 hours on Day 1; leucovorin (LV) 400 mg/m² intravenously over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus on Day 1, followed by continuous intravenous infusion of 1200 mg/(m²·day) for 2 days (total dose 2400 mg/m², infused over 46-48 hours). | Drug | Savolitinib plus cetuximab and FOLFOX chemotherapy |
| Cetuximab and FOLFOX chemotherapyCetuximab: Administered intravenously at an initial dose of 400 mg/m² prior to chemotherapy, followed by a weekly dose of 250 mg/m² infused over 1 hour. FOLFOX chemotherapy regimen: Oxaliplatin 85 mg/m² intravenously over 2 hours on Day 1; leucovorin (LV) 400 mg/m² intravenously over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus on Day 1, followed by continuous intravenous infusion of 1200 mg/(m²·day) for 2 days (total dose 2400 mg/m², infused over 46-48 hours). | Drug | Cetuximab plus FOLFOX chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
The incidence of confirmed complete response or partial response
6 secondary outcomes
Progression free survival (PFS)
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Disease control rate (DCR)
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Duration of response (DOR)
Time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
Time to response (TTR)
Time frame: From date of first dose of study drug until partial response (up to approximately 12 months)
Overall survival (OS)
Time frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 24 months)
Number and Proportion of patients with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: From the date of first dose of study drug to 90 days after the last administration
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
5 sites 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 Savolitinib plus cetuximab and FOLFOX chemotherapy and Cetuximab and FOLFOX chemotherapy in people with Colorectal Cancer (CRC), run by Fudan University at 5 sites 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 15 inclusion and 24 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Jianmin Xu, Phd (021-64041990, xujmin@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)). 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 6 Jul 2026.