Back to resultsA Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ametumumab
Anti-PD-1 monoclonal antibody
Cetuximab
FOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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.
Sites / Locations
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Ametumumab (Q2W) + FOLFIRI;
Cetuximab + FOLFIRI;
Arm Description
Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
Secondary Outcome Measures
Objective Response Rate (ORR)
incidence of adverse events
Full Information
NCT ID
NCT05684211
First Posted
January 4, 2023
Last Updated
January 30, 2023
Sponsor
Shanghai Celfuture Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05684211
Brief Title
A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Celfuture Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical 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.
Detailed Description
This is a multicenter, open-label, parallel-group, randomised, phase IIb trial. This study is to evaluate and compare the efficacy and safety of Ametumumab (anti-EGFR monoclonal antibody) combined with anti-PD-1 monoclonal antibody in first-line treatment of RAS wild-type colorectal cancer patients, as well as to assess the immunogenicity and pharmacokinetic profile and recommend dosing regimen for phase III clinical trials.Conditions and keywords.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Arm Type
Active Comparator
Arm Description
Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
Arm Title
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Arm Type
Active Comparator
Arm Description
Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;
Arm Title
Ametumumab (Q2W) + FOLFIRI;
Arm Type
Active Comparator
Arm Description
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
Arm Title
Cetuximab + FOLFIRI;
Arm Type
Active Comparator
Arm Description
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
Intervention Type
Drug
Intervention Name(s)
Ametumumab
Intervention Description
A recombinant fully human anti-EGFR monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Anti-PD-1 monoclonal antibody
Intervention Description
Toripalimab 3 mg/kg，Intravenous titration，Q2W
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab 500 mg/m2 ，Intravenous titration，Q2W
Intervention Type
Drug
Intervention Name(s)
FOLFIRI
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kongli Zhu, Master
Phone
15800363686
Email
tsl-zukongli@tasly.com
Facility Information:
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan, MD
Phone
13605716662
Email
panhongming@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
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