HER2Phase 4HCCSC-C03NCT05661357
Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression
A Phase 4 study testing Disitamab Vedotin Combined With Fruquintinib in people with HER2 and Colorectal Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2, Colorectal Cancer
- What is being tested?
- Disitamab Vedotin Combined With Fruquintinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Colorectal cancer patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0-1;
- Patients with advanced colorectal cancer who are pathologically diagnosed as HER2 expression or mutation and who fail or are intolerant after second-line treatment; Note: HER2 expression refers to patients with tumor cell immunohistochemical staining intensity of 1+, 2+or 3+confirmed to have expression at least once in the pathological detection/review of primary or metastatic lesions conducted by the pathology department of our hospital, or patients with advanced colorectal cancer with HER2 gene amplification or mutation confirmed by NGS.
- According to RECIST 1.1 standard, there is at least one measurable target lesion, and tumor imaging evaluation is conducted within 28 days before the first drug use;
- Estimated survival time ≥ 12 weeks;
- If the main organs function normally, they meet the following standards:
- The blood routine examination standard should meet: ANC ≥ 1.5 × 109/L； PLT ≥90 × 109/L； Hb ≥ 90g/L (no blood transfusion within 14 days); (2) Biochemical examination shall meet the following standards: ALB ≥ 30g/L; (No ALB within 14 days); TBIL ≤ upper limit of normal value (ULN); ALT and AST ≤ 2.5 times the upper limit of normal value (ULN). If there is liver metastasis, ALT and AST ≤ 5ULN; Alkaline phosphatase ≤ 2.5 times the upper limit of normal value (ULN); BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft Gault formula); (3) Color Doppler echocardiography and echocardiography: left ventricular ejection fraction (LVEF ≥ 50%); (4) QT interval (QTcF) corrected by Fridericia method of 12 lead ECG in women<470 ms; 7. For female patients without menopause or surgical sterilization: during the treatment period and at least 7 months after the last administration of the drug in the study treatment, agree to abstinence or use effective contraception methods; 8. Volunteer to join the study and sign the informed consent form.
Who cannot join
- Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past;
- At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy;
- The patient has undergone major surgery unrelated to colorectal cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgery;
- Serious heart disease or discomfort, including but not limited to the following diseases:
- History of diagnosis of heart failure or systolic dysfunction (LVEF<50%)
- High risk uncontrolled arrhythmia, such as atrial tachycardia, resting heart rate>100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (i.e. Mobitz II second degree atrioventricular block or third degree atrioventricular block)
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- Angina requiring anti angina drugs
- Valvular heart disease with clinical significance
- ECG showed transmural myocardial infarction
- Poor control of hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg)
- Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption;
- People known to have a history of allergy to the drug components of this protocol; Have a history of immunodeficiency, including HIV test positive, HBV/HCV test positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- Women in pregnancy and lactation, women with fertility and positive baseline pregnancy test, or women in childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study drug use;
- Suffer from serious concomitant diseases or other concomitant diseases that may interfere with the planned treatment, or The investigator believes that the patient is not suitable to participate in any other situation of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm, Prospective, Exploratory Clinical Study of Disitamab Vedotin Combined With Fruquintinib for Advanced Colorectal Cancer With HER2 Expression or Mutation That Has Received at Least Two Standard Treatment Failures
Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures
Read the detailed description
Colorectal cancer is the fourth deadliest malignant tumor in the world, and the 5-year survival rate of patients with advanced colorectal cancer is only 12%. In September 2018, furoquentinib was the first approved in China for the treatment of metastatic colorectal cancer patients who failed to receive at least two systematic anti-tumor treatments. The FRESCO trial is a multicenter (28 hospitals in China), randomized, double-blind and placebo controlled phase III trial, The median OS of patients receiving furoxigenib was 9.3 months, while the mOS of patients receiving placebo was 6.57 months (HR=0.65, 95% CI: 0.51~0.83, P<0.001); As a secondary endpoint, mPFS was 3.71 and 1.84 months (HR=0.26, 95% CI: 0.21~0.34, P<0.001). In order to further improve the efficacy, it is necessary to continue to explore the combined treatment strategy of furoquentinib: combined chemotherapy, other targeted treatment and local treatment may benefit more CRC patients. HER2 amplification or overexpression was found in 2%~6% of patients with advanced or metastatic colorectal cancer. In the past decade, several studies have identified it as a potential target for the treatment of HER2 positive colorectal cancer, and it has been written into the guidelines for posterior line therapy. The prognostic value of HER2 overexpression in advanced colorectal cancer is still unclear. The anti-tumor activity of dual targeted HER2 treatment schemes, such as Patuzumab+Trastuzumab, Trastuzumab+Tucatinib, Trastuzumab+Lapatinib, has been significantly increased, which has been confirmed in clinical studies. Vidiximab contains a new humanized anti HER2 antibody Disitamab, which is coupled to monomethylolestatin E (MMAE) through a cleavable linker. Its antibody has a high affinity for HER2 and can efficiently bind with it and enter cancer cells; The linker is cleavable in the tumor cell membrane, which can rapidly release small molecule cytotoxic drugs, and has a bystander killing effect against heterogeneous tumor cells. This one arm, prospective, open study was designed to explore the efficacy and safety of vidiximab combined with furoquentinib triple line or above in the treatment of advanced colorectal cancer with HER2 expression or mutation.
- Conditions
- HER2, Colorectal Cancer
- Being tested
- Disitamab Vedotin Combined With Fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin Combined With FruquintinibDrug
Furquinotinib: 3mg, Qd, 28 days as a cycle. Vidicizumab: according to the instructions of Vidicizumab, d1, 2.5 mg/kg, intravenous drip (ivgtt)
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin combined with Fruquintinib | Experimental | Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures Receives: Drug: Disitamab Vedotin Combined With Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huangshi Central Hospital, The First People's Hospital of Tianmen, Sir Run Run Shaw Hospital, Hubei Cancer Hospital
- Responsible party
- Principal investigator, Zhou Fuxiang, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661357
- Sponsor's protocol ID
- HCCSC C03
- Acronym
- HCCSC-C03
- Status last verified
- Apr 2024
- First submitted
- 8 Nov 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Prospective, Exploratory Clinical Study of Disitamab Vedotin Combined With Fruquintinib for Advanced Colorectal Cancer With HER2 Expression or Mutation That Has Received at Least Two Standard Treatment Failures
- ClinicalTrials.gov ID
- NCT05661357
- Acronym / sponsor ID
- HCCSC-C03 / HCCSC C03
- Conditions
- HER2, Colorectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Huangshi Central Hospital, The First People's Hospital of Tianmen, Sir Run Run Shaw Hospital, Hubei Cancer Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 2022 (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.
Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures
Detailed description
Colorectal cancer is the fourth deadliest malignant tumor in the world, and the 5-year survival rate of patients with advanced colorectal cancer is only 12%. In September 2018, furoquentinib was the first approved in China for the treatment of metastatic colorectal cancer patients who failed to receive at least two systematic anti-tumor treatments. The FRESCO trial is a multicenter (28 hospitals in China), randomized, double-blind and placebo controlled phase III trial, The median OS of patients receiving furoxigenib was 9.3 months, while the mOS of patients receiving placebo was 6.57 months (HR=0.65, 95% CI: 0.51~0.83, P<0.001); As a secondary endpoint, mPFS was 3.71 and 1.84 months (HR=0.26, 95% CI: 0.21~0.34, P<0.001). In order to further improve the efficacy, it is necessary to continue to explore the combined treatment strategy of furoquentinib: combined chemotherapy, other targeted treatment and local treatment may benefit more CRC patients. HER2 amplification or overexpression was found in 2%~6% of patients with advanced or metastatic colorectal cancer. In the past decade, several studies have identified it as a potential target for the treatment of HER2 positive colorectal cancer, and it has been written into the guidelines for posterior line therapy. The prognostic value of HER2 overexpression in advanced colorectal cancer is still unclear. The anti-tumor activity of dual targeted HER2 treatment schemes, such as Patuzumab+Trastuzumab, Trastuzumab+Tucatinib, Trastuzumab+Lapatinib, has been significantly increased, which has been confirmed in clinical studies. Vidiximab contains a new humanized anti HER2 antibody Disitamab, which is coupled to monomethylolestatin E (MMAE) through a cleavable linker. Its antibody has a high affinity for HER2 and can efficiently bind with it and enter cancer cells; The linker is cleavable in the tumor cell membrane, which can rapidly release small molecule cytotoxic drugs, and has a bystander killing effect against heterogeneous tumor cells. This one arm, prospective, open study was designed to explore the efficacy and safety of vidiximab combined with furoquentinib triple line or above in the treatment of advanced colorectal cancer with HER2 expression or mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin combined with Fruquintinib | Experimental | Drug: Disitamab Vedotin Combined With FruquintinibSingle arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Colorectal cancer patients aged ≥ 18 years and ≤ 75 years;
- ECOG score 0-1;
- Patients with advanced colorectal cancer who are pathologically diagnosed as HER2 expression or mutation and who fail or are intolerant after second-line treatment; Note: HER2 expression refers to patients with tumor cell immunohistochemical staining intensity of 1+, 2+or 3+confirmed to have expression at least once in the pathological detection/review of primary or metastatic lesions conducted by the pathology department of our hospital, or patients with advanced colorectal cancer with HER2 gene amplification or mutation confirmed by NGS.
- According to RECIST 1.1 standard, there is at least one measurable target lesion, and tumor imaging evaluation is conducted within 28 days before the first drug use;
- Estimated survival time ≥ 12 weeks;
Key exclusion criteria (14 listed)
- Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past;
- At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy;
- The patient has undergone major surgery unrelated to colorectal cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgery;
- Serious heart disease or discomfort, including but not limited to the following diseases:
- Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption;
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 |
|---|---|---|
| Disitamab Vedotin Combined With FruquintinibFurquinotinib: 3mg, Qd, 28 days as a cycle. Vidicizumab: according to the instructions of Vidicizumab, d1, 2.5 mg/kg, intravenous drip (ivgtt) | Drug | Disitamab Vedotin combined with Fruquintinib |
Primary outcome
ORR
Time frame: through study completion, an average of 2 years
Objective Response Rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Disitamab Vedotin Combined With Fruquintinib in people with HER2 and Colorectal Cancer, run by Zhongnan Hospital 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: through study completion, an average of 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 17 Apr 2024.