- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684211
A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
A Multicenter, Open-label, Parallel-group,Randomised, Phase IIb Trial of Efficacy and Safety of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI Versus Ametumumab or Cetuximab in Combination With FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: kongli Zhu, Master
- Phone Number: 15800363686
- Email: tsl-zukongli@tasly.com
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Contact:
- Hongming Pan, MD
- Phone Number: 13605716662
- Email: panhongming@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Voluntarily sign written informed consent; Age 18 ~ 85 years (inclusive), male or female;
•Patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; RAS (KRAS, NRAS) gene is wild-type and no BRAF V600E mutation has been identified; Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST 1.1 criteria; Performance status (ECOG) score 0 or 1.
Exclusion Criteria:
Previous chemotherapy for colorectal cancerPrevious treatment with anti-EGFR monoclonal antibodies Received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose.
Radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy Participation in other clinical trials within 4 weeks prior to enrollment; Severe skin disease requiring systemic treatment. Presence of serious clinical infection.\ Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ametumumab+ anti-PD-1 monoclonal antibody+ FOLFIRI
Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
|
A recombinant fully human anti-EGFR monoclonal antibody
Toripalimab 3 mg/kg,Intravenous titration,Q2W
Rinotecan hydrochloride,180mg/m2,intravenous titration,Q2W; 5 -Fluorouracil,400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration,Q2W
|
Active Comparator: Ametumumab + anti-PD-1 monoclonal antibody + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
|
A recombinant fully human anti-EGFR monoclonal antibody
Toripalimab 3 mg/kg,Intravenous titration,Q2W
Rinotecan hydrochloride,180mg/m2,intravenous titration,Q2W; 5 -Fluorouracil,400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration,Q2W
|
Active Comparator: Ametumumab (Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
|
A recombinant fully human anti-EGFR monoclonal antibody
Rinotecan hydrochloride,180mg/m2,intravenous titration,Q2W; 5 -Fluorouracil,400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration,Q2W
|
Active Comparator: Cetuximab + FOLFIRI;
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
|
Rinotecan hydrochloride,180mg/m2,intravenous titration,Q2W; 5 -Fluorouracil,400 mg/ m2, intravenous push, then 1200 mg/ m2 /day x 2 days, intravenous titration,Q2W; Calcium folinate,400mg/m2,intravenous titration,Q2W
Cetuximab 500 mg/m2 ,Intravenous titration,Q2W
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS)
Time Frame: PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. approximately 45 months
|
PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. approximately 45 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate (ORR)
Time Frame: ORR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy, approximately 45 months.
|
ORR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy, approximately 45 months.
|
incidence of adverse events
Time Frame: Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months
|
Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Antibodies
- Antibodies, Monoclonal
- Cetuximab
Other Study ID Numbers
- WBP252-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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