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Trial Title:
A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
NCT ID:
NCT05684211
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ametumumab
Description:
A recombinant fully human anti-EGFR monoclonal antibody
Arm group label:
Ametumumab (Q2W) + FOLFIRI;
Arm group label:
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Arm group label:
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
Toripalimab 3 mg/kg，Intravenous titration，Q2W
Arm group label:
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Arm group label:
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab 500 mg/m2 ，Intravenous titration，Q2W
Arm group label:
Cetuximab + FOLFIRI;
Intervention type:
Drug
Intervention name:
FOLFIRI
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
Arm group label:
Ametumumab (Q2W) + FOLFIRI;
Arm group label:
Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI
Arm group label:
Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;
Arm group label:
Cetuximab + FOLFIRI;
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Hongming Pan, MD
Phone:
13605716662
Email:
panhongming@zju.edu.cn
Start date:
January 2023
Completion date:
January 2023
Lead sponsor:
Agency:
Shanghai Celfuture Biotech Co., Ltd.
Agency class:
Industry
Source:
Shanghai Celfuture Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05684211
