Advanced Colorectal CancerPhase 2SUPβORTNCT07000305
A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer
A Phase 2 study testing Cetuximabβ combined with Envolimab and mFOLFOX6 in people with Advanced Colorectal Cancer, run by Tao Zhang at 1 site in China.
Trial summary
A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Cetuximabβ combined with Envolimab and mFOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 20 May 2028
- 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
- have agreed and signed an informed consent form (ICF) and are willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.
- At the time of signing the ICF, patients must be ≥18 years of age and have a life expectancy of ≥12 weeks in either males or females.
- Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma.
- Advanced or metastatic colorectal cancer (AJCC/UICC stage IV) clearly defined by imaging, with at least one measurable lesion that meets the requirements of the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1).
- no prior systemic therapy (including epidermal growth factor receptor inhibitors such as cetuximab or panitumumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, and anti-CTLA-4 antibodies) directed against advanced or metastatic colorectal cancer, but are allowed to receive a maximum of one cycle of the mFOLFOX6 regimen prior to enrollment ; Adjuvant/neoadjuvant therapy is considered a first-line systemic therapy for advanced or metastatic disease if recurrence or metastasis occurs during or within 6 months of completion of adjuvant or neoadjuvant chemotherapy.
- an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.
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- have appropriate organ function during the screening period:
- Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study drug administration and be willing to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration; for male subjects whose partner is a female of childbearing potential, he/she should be surgically sterilized or agree to use a medically approved highly effective contraceptive measure (e.g., IUD, birth control pills, or condoms) during the study period and for 3 months after final study drug administration. 3 months after the final study dose.
- Participation in other clinical trials during the study period is not permitted.
Who cannot join
- previous or concurrent other active malignancies (except for malignancies that have been curatively treated and have been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).
- Current gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator.
- Thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis within 12 months prior to enrollment in the study.
- Myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure within 12 months prior to study entry.
- systemic antibiotic use for ≥ 7 days within 4 weeks prior to study entry or unexplained fever > 38.5°C during screening/prior to first dose (fever due to oncologic causes is eligible for enrollment at the discretion of the investigator).
- Presence of hydrothorax, ascites, or pericardial effusion uncontrolled with effective therapy within 14 days prior to study entry.
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- Presence of any prior treatment-induced, unabated adverse event Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) Grade 2 or greater toxicity (excluding anemia, alopecia, and skin hyperpigmentation).
- Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonia).
- Human Immunodeficiency Virus (HIV) infection or known Acquired Immune Deficiency Syndrome (AIDS), untreated active hepatitis (Hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; and Hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with Hepatitis B and Hepatitis C.
- Known or suspected history of allergy to any of the drugs of interest used in the study.
- Pregnant or lactating women.
- Women of childbearing potential (< 2 years after last menstrual period) or men of childbearing potential who are not using or refuse to use an effective non-hormonal contraceptive.
- Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable 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.
Yan Junsi contact
China1 site
Union Hospital, Tongji Medical College, Huazhong University Hospita
Wuhan, Hubei, 430000
lunli Medical Ethics Committee, 027-85726375, whunionlunli@126.com
About this study
Official title: Cetuximabβ Combined With Envolimab and mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable , Metastatic Colorectal Cancer: A Single-arm, Multi-center, Phase II Trail
A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Cetuximabβ combined with Envolimab and mFOLFOX6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximabβ combined with Envolimab and mFOLFOX6Drug
Envolimab, 200 mg, sc, day 1; Cetuximabβ 500 mg/m2 IV over 60- 120 min, day 1; chemotherapy mFOLFOX6; with the above regimen every 14 days for 1 treatment cycle. Then patients who did not experience disease progression within 8-12 cycles were entered into maintenance therapy, which consisted of a fluorouracil-based-chemotherapy with Cetuximabβ and Envolimab regimen until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | All subjects meeting the enrollment criteria will receive 8-12 cycles of induction phase treatment with envolimab in combination with cetuximab beta and mFOLFOX6 regimen, and enter into maintenance therapy after assessment of no disease progression, with maintenance regimen of envolimab in combination with cetuximabβ and a fluorouracil-based chemotherapeutic agent (selected by the investigator) Receives: Drug: Cetuximabβ combined with Envolimab and mFOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Secondary outcomes (5)
Objective response rate (ORR)
The efficacy of solid tumors was evaluated according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1).
Measured: Through out the study (up to 2 years)
disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
No Evidence of Disease, NED
Percentage of all subjects who received study treatment with no evidence of tumor presence by current investigations (pathology, imaging, molecular biology, etc.).
Measured: Through out the study (up to 2 years)
Overall survival (OS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Measured: Through out the study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start20 May 2025 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000305
- Sponsor's protocol ID
- SMA-CRC-004
- Acronym
- SUPβORT
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 2 Jun 2025
- 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 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cetuximabβ Combined With Envolimab and mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable , Metastatic Colorectal Cancer: A Single-arm, Multi-center, Phase II Trail
- ClinicalTrials.gov ID
- NCT07000305
- Acronym / sponsor ID
- SUPβORT / SMA-CRC-004
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 2 Jun 2025 (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.
A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Cetuximabβ combined with Envolimab and mFOLFOX6All subjects meeting the enrollment criteria will receive 8-12 cycles of induction phase treatment with envolimab in combination with cetuximab beta and mFOLFOX6 regimen, and enter into maintenance therapy after assessment of no disease progression, with maintenance regimen of envolimab in combination with cetuximabβ and a fluorouracil-based chemotherapeutic agent (selected by the investigator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- have agreed and signed an informed consent form (ICF) and are willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.
- At the time of signing the ICF, patients must be ≥18 years of age and have a life expectancy of ≥12 weeks in either males or females.
- Histologically or cytologically confirmed RAS and BRAF wild-type, MSS type colorectal adenocarcinoma.
- Advanced or metastatic colorectal cancer (AJCC/UICC stage IV) clearly defined by imaging, with at least one measurable lesion that meets the requirements of the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1).
- no prior systemic therapy (including epidermal growth factor receptor inhibitors such as cetuximab or panitumumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, and anti-CTLA-4 antibodies) directed against advanced or metastatic colorectal cancer, but are allowed to receive a maximum of one cycle of the mFOLFOX6 regimen prior to enrollment ; Adjuvant/neoadjuvant therapy is considered a first-line systemic therapy for advanced or metastatic disease if recurrence or metastasis occurs during or within 6 months of completion of adjuvant or neoadjuvant chemotherapy.
Key exclusion criteria (13 listed)
- previous or concurrent other active malignancies (except for malignancies that have been curatively treated and have been free of morbidity for more than 5 years or carcinoma in situ that can be cured by adequate treatment).
- Current gastrointestinal diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator.
- Thrombotic or embolic events such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, deep vein thrombosis within 12 months prior to enrollment in the study.
- Myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure within 12 months prior to study entry.
- systemic antibiotic use for ≥ 7 days within 4 weeks prior to study entry or unexplained fever > 38.5°C during screening/prior to first dose (fever due to oncologic causes is eligible for enrollment at the discretion of the investigator).
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 |
|---|---|---|
| Cetuximabβ combined with Envolimab and mFOLFOX6Envolimab, 200 mg, sc, day 1; Cetuximabβ 500 mg/m2 IV over 60- 120 min, day 1; chemotherapy mFOLFOX6; with the above regimen every 14 days for 1 treatment cycle. Then patients who did not experience disease progression within 8-12 cycles were entered into maintenance therapy, which consisted of a fluorouracil-based-chemotherapy with Cetuximabβ and Envolimab regimen until progression or unacceptable toxicity. | Drug | experimental group |
Primary outcome
Progression-free survival (PFS)
Time frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
5 secondary outcomes
Objective response rate (ORR)
Time frame: Through out the study (up to 2 years)
disease control rate (DCR)
Time frame: Through out the study (up to 2 years)
No Evidence of Disease, NED
Time frame: Through out the study (up to 2 years)
Overall survival (OS)
Time frame: Through out the study (up to 2 years)
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Time frame: Through out the study (up to 2 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 2 Jun 2025.
- 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.
Yan Junsi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximabβ combined with Envolimab and mFOLFOX6 in people with Advanced Colorectal Cancer, run by Tao Zhang 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 9 inclusion and 13 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 2 Jun 2025. 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 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 LI LI (+8617702740317, lili9@zaiming.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Through out the study (up to 2 years)). 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 2 Jun 2025.