A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT05684211
- Lead Sponsor
- Shanghai Celfuture Biotech Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 84
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI FOLFIRI Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Ametumumab (Q2W) + FOLFIRI; Ametumumab Ametumumab 450 mg/m2 (Q2W) + FOLFIRI Ametumumab (Q2W) + FOLFIRI; FOLFIRI Ametumumab 450 mg/m2 (Q2W) + FOLFIRI Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI Ametumumab Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI Anti-PD-1 monoclonal antibody Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; Anti-PD-1 monoclonal antibody Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; FOLFIRI Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Cetuximab + FOLFIRI; FOLFIRI Cetuximab 500 mg/m2 (Q2W) + FOLFIRI Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI; Ametumumab Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI; Cetuximab + FOLFIRI; Cetuximab Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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
Name Time Method Objective Response Rate (ORR) 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 Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months
Trial Locations
- Locations (1)
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China