RAS Wild Type mCRCPhase 2NCT07490119
Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer
A Phase 2 study testing Becotatug Vedotin and Cetuximab in people with RAS Wild Type mCRC, run by Fudan University.
Trial summary
This is a single-arm, single-center, exploratory study aimed at exploring the treatment of RAS wild-type recurrent/metastatic colorectal cancer with the combination of becotatug vedotin and cetuximab as a salvage therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RAS Wild Type mCRC
- What is being tested?
- Becotatug Vedotin and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Phase 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
- Volunteer to sign the informed consent form, fully understand and sign the informed consent (ICF) for this study willing to follow and capable of completing all trial procedures
- No gender restriction, aged ≥18 years (as of the day of signing the informed consent form)
- Histologically or cytologically confirmed metastatic RAS wild-type colorectal cancer
- Patients should have received the following treatments:
- 1) previously received chemotherapy based on oxaliplatin and/or irinotecan 2) received anti-vascular endothelial growth factor (VEGF) treatment or anti-epidermal growth factor receptor (EGFR) treatment for left-sided colorectal cancer 3) for patients diagnosed with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), they also need to have received treatment with programmed death protein-1 (PD-1) or its ligand (PD-L1) inhibitors 4) subjects without BRAF mutations. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), subjects must have at least one measurable lesion (lesion with a longest diameter ≥10mm). 6. Within 7 days before the first dose, physical condition score according to the Eastern Cooperative Oncology Group (ECOG) standard is 0 or 1. 7. Expected survival ≥12 weeks. 8. Have appropriate organs and hematopoietic function (no blood transfusion or use of any cell growth factors within 14 days before the first use of study drugs), according to the following laboratory tests: 1) Neutrophil count (NEUT#) ≥1.5×10^9/L platelet count ≥75×10^9/L 2) Hemoglobin ≥85g/L 3) Serum creatinine ≤1.5 times the upper limit of normal (ULN) 4) AST, ALT ≤2.5 times ULN (can be relaxed to ≤5 times ULN for patients with liver metastasis) 5) Total bilirubin (TBIL) ≤1.5 times ULN 6) International normalized ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN (except for patients undergoing anticoagulant therapy).
- 9. For female patients with reproductive capacity, blood pregnancy test results should be negative within 7 days before treatment 10.Female subjects of childbearing age and male subjects whose partners are female subjects of childbearing age must agree to use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicide) for contraception from the time they sign the informed consent form until one year after the last administration of study medication. Subjects must have good compliance.
Who cannot join
- Presence of ≥ Grade 2 peripheral neuropathy (based on CTCAE 5.0)
- Expected to require surgery or any other form of systemic or local anti-tumor treatment during the study period
- Having undergone any of the following treatments: 1) Previously receiving antibody-conjugated drugs loaded with methotrexate
- 2) Receiving study drugs from other clinical trials within 28 days prior to the first dose
- 3) Receiving radiotherapy within 28 days prior to the first dose or palliative radiotherapy for bone metastases within 2 weeks
- 4) Receiving any anti-tumor drugs within 3 weeks prior to the first dose (whichever is shorter, with a washout period of ≥14 days for oral fluoropyrimidine derivatives, folinic acid derivatives, and weekly intensive paclitaxel chemotherapy, and a washout period of ≥42 days for nitrosoureas and mitomycin). 4. Known active central nervous system metastases and/or carcinomatous meningitis. Treated brain metastasis subjects may participate in the study, provided that their condition is stable and they do not have any of the following conditions: 1) Progressive or new-onset neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache
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- 2) Evidence of recurrence/progression on MRI at least 4 weeks prior to the first dose of study treatment, and any neurological symptoms have not returned to baseline levels
- 3) Evidence of new brain metastases or enlargement of brain metastases, requiring the use of corticosteroids at least 3 days prior to the administration of study drugs. 5. Known history of malignant tumors (excluding subjects who have successfully undergone definitive surgery for cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma, or cervical carcinoma in situ), unless the subject has received potentially curative treatment and has not experienced disease recurrence within 5 years since the start of treatment. 6. Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites requiring ≥1 drainage per month
- 7. Tumor invasion into important arteries leading to high-risk bleeding risk, with significant perforation risk or already formed fistulas
- 8. Residual toxic reactions (excluding hair loss, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory test abnormalities above Grade 1 (CTCAE v5.0) due to previous anti-tumor treatment (including biologics, targeted therapy, chemotherapy, or radiotherapy)
- 9. History of severe cardiac dysfunction, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment. History of ventricular tachycardia or torsade de pointes arrhythmia. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG), such as QTc > 450 ms in males and QTc > 470 ms in females, presence of complete left bundle branch block or third-degree atrioventricular block. Presence of clinically significant cardiac diseases, including acute myocardial infarction, Grade III or IV congestive heart failure (New York Heart Association classification), unstable angina pectoris, or arrhythmias requiring treatment, occurring within 6 months prior to the first study treatment. Note: Subjects with arrhythmias may be enrolled if they are receiving antiarrhythmic drug therapy and the screening electrocardiogram (ECG) shows a controlled rhythm
- 10. Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug
- 11. Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) or hyperglycemia
- 12. Active acute or chronic inflammatory skin diseases, previous history of Steven-Johnson syndrome, toxic epidermal necrolysis
- 13. Known hypersensitivity to any component or excipient of Vibecotar (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80), or known hypersensitivity to other previous anti-EGFR drugs (including the investigational study drug) or other monoclonal antibodies with a grade ≥3 reaction
- 14. Known active hepatitis B or C. Active hepatitis B is defined as known HBsAg positivity and HBV DNA ≥500 IU/mL. Active hepatitis C is defined as known hepatitis C antibody positivity and known quantitative hepatitis C virus (HCV) RNA result greater than the lower limit of detection. Presence of other severe liver diseases, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH)
- 15. Concurrent severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosis of acquired immune deficiency syndrome (AIDS) or uncontrolled autoimmune disease
- 16. Subjects with active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infective therapy (unless treated and resolved prior to study drug administration)
- 17. Subjects with moderate to severe dyspnea at rest due to advanced cancer or its complications, or severe primary lung disease (currently requiring continuous oxygen therapy and with oxygen saturation <93% without supplemental oxygen), or any history of interstitial lung disease (ILD) (including ILD requiring oral or intravenous corticosteroids) or non-infectious pneumonia
- 18. Subjects undergoing immunology-based therapy for any reason, including long-term systemic steroid use equivalent to >10 mg/day of prednisone within 7 days prior to the first dose of study drug or at any time during the study participation. Note: Inhaled or topical steroids equivalent to ≤10 mg/day of prednisone, or short-term use of corticosteroids equivalent to >10 mg/day of prednisone (e.g., as prophylaxis before contrast media administration) is permitted
- 19. Subjects with chronic autoimmune or inflammatory diseases requiring systemic treatment or undergoing systemic treatment within the past 2 years, including but not limited to inflammatory bowel disease, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (exceptions: vitiligo, hypothyroidism undergoing stable hormone replacement therapy, controlled asthma, type I diabetes, Graves' disease, and Hashimoto's thyroiditis)
- 20. Subjects who test positive for pregnancy or are breastfeeding. Female and male subjects who do not plan to use adequate contraception during the treatment period and within 180 days after the last dose of study treatment any other diseases or clinically significant laboratory parameter abnormalities, severe medical or psychiatric conditions/conditions, and substance abuse including alcohol abuse, that the investigator believes may compromise subject safety, study integrity, affect subject participation in the study, or interfere with study objectives and outcome analysis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer: A Single-arm, Open-label, Single-center Phase II Clinical Study
This is a single-arm, single-center, exploratory study aimed at exploring the treatment of RAS wild-type recurrent/metastatic colorectal cancer with the combination of becotatug vedotin and cetuximab as a salvage therapy
- Conditions
- RAS Wild Type mCRC
- Being tested
- Becotatug Vedotin, Cetuximab
- Keywords
- EGFR-ADC, Becotatug Vedotin, Cetuximab, mCRC, RAS wild type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
Also called MRG003
On the first day of every 3 weeks, Becotatug Vedotin will be administered via intravenous infusion at 2.0 mg/kg.
CetuximabDrug
On the first day of every 2 weeks, Cetuximab will be administered via intravenous infusion at 500mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin + Cetuximab | Experimental | Not described Receives: Drug: Becotatug Vedotin; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: From enrollment to the end of treatmen at 1 year
Secondary outcomes (4)
PFS
Measured: From enrollment to the end of treatment at 1 years
DOR
Measured: From enrollment to the end of treatment at 1 years
DCR
Measured: From enrollment to the end of treatment at 1 years
OS
Measured: From enrollment to the end of treatment at 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS Wild Type mCRCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Cancer Hospital, China
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490119
- Sponsor's protocol ID
- GWK-2025-010
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer: A Single-arm, Open-label, Single-center Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07490119
- Acronym / sponsor ID
- GWK-2025-010
- Conditions
- RAS Wild Type mCRC
- Keywords
- EGFR-ADC, Becotatug Vedotin, Cetuximab, mCRC, RAS wild type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Cancer Hospital, China
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 24 Mar 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 single-arm, single-center, exploratory study aimed at exploring the treatment of RAS wild-type recurrent/metastatic colorectal cancer with the combination of becotatug vedotin and cetuximab as a salvage therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin + Cetuximab | Experimental | Drug: Becotatug Vedotin, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteer to sign the informed consent form, fully understand and sign the informed consent (ICF) for this study willing to follow and capable of completing all trial procedures
- No gender restriction, aged ≥18 years (as of the day of signing the informed consent form)
- Histologically or cytologically confirmed metastatic RAS wild-type colorectal cancer
- Patients should have received the following treatments:
- 1) previously received chemotherapy based on oxaliplatin and/or irinotecan 2) received anti-vascular endothelial growth factor (VEGF) treatment or anti-epidermal growth factor receptor (EGFR) treatment for left-sided colorectal cancer 3) for patients diagnosed with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), they also need to have received treatment with programmed death protein-1 (PD-1) or its ligand (PD-L1) inhibitors 4) subjects without BRAF mutations. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), subjects must have at least one measurable lesion (lesion with a longest diameter ≥10mm). 6. Within 7 days before the first dose, physical condition score according to the Eastern Cooperative Oncology Group (ECOG) standard is 0 or 1. 7. Expected survival ≥12 weeks. 8. Have appropriate organs and hematopoietic function (no blood transfusion or use of any cell growth factors within 14 days before the first use of study drugs), according to the following laboratory tests: 1) Neutrophil count (NEUT#) ≥1.5×10^9/L platelet count ≥75×10^9/L 2) Hemoglobin ≥85g/L 3) Serum creatinine ≤1.5 times the upper limit of normal (ULN) 4) AST, ALT ≤2.5 times ULN (can be relaxed to ≤5 times ULN for patients with liver metastasis) 5) Total bilirubin (TBIL) ≤1.5 times ULN 6) International normalized ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN (except for patients undergoing anticoagulant therapy).
Key exclusion criteria (22 listed)
- Presence of ≥ Grade 2 peripheral neuropathy (based on CTCAE 5.0)
- Expected to require surgery or any other form of systemic or local anti-tumor treatment during the study period
- Having undergone any of the following treatments: 1) Previously receiving antibody-conjugated drugs loaded with methotrexate
- 2) Receiving study drugs from other clinical trials within 28 days prior to the first dose
- 3) Receiving radiotherapy within 28 days prior to the first dose or palliative radiotherapy for bone metastases within 2 weeks
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 |
|---|---|---|
| Becotatug VedotinAlso: MRG003On the first day of every 3 weeks, Becotatug Vedotin will be administered via intravenous infusion at 2.0 mg/kg. | Drug | Becotatug Vedotin + Cetuximab |
| CetuximabOn the first day of every 2 weeks, Cetuximab will be administered via intravenous infusion at 500mg/m2 | Drug | Becotatug Vedotin + Cetuximab |
Primary outcome
ORR
Time frame: From enrollment to the end of treatmen at 1 year
4 secondary outcomes
PFS
Time frame: From enrollment to the end of treatment at 1 years
DOR
Time frame: From enrollment to the end of treatment at 1 years
DCR
Time frame: From enrollment to the end of treatment at 1 years
OS
Time frame: From enrollment to the end of treatment at 1 years
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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Real-World Treatment Patterns and Effectiveness of Anti-EGFR- and Anti-VEGF-based Therapies in Left-sided RAS Wild-Type Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruitingPhase 3
Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
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Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin and Cetuximab in people with RAS Wild Type mCRC, run by Fudan University.
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 6 inclusion and 22 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 LU WANG (+86 18121299555, cms024mm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From enrollment to the end of treatmen at 1 year). 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 24 Mar 2026.