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
Overview
- Phase
- Phase 2
- Intervention
- Ametumumab
- Conditions
- Colorectal Cancer
- Sponsor
- Shanghai Celfuture Biotech Co., Ltd.
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Ametumumab (QW) + 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;
Intervention: Ametumumab
Ametumumab (QW) + 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;
Intervention: Anti-PD-1 monoclonal antibody
Ametumumab (QW) + 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;
Intervention: FOLFIRI
Ametumumab(Q2W) + 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;
Intervention: Ametumumab
Ametumumab(Q2W) + 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;
Intervention: Anti-PD-1 monoclonal antibody
Ametumumab(Q2W) + 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;
Intervention: FOLFIRI
Ametumumab (Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
Intervention: Ametumumab
Ametumumab (Q2W) + FOLFIRI;
Ametumumab 450 mg/m2 (Q2W) + FOLFIRI
Intervention: FOLFIRI
Cetuximab + FOLFIRI;
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
Intervention: Cetuximab
Cetuximab + FOLFIRI;
Cetuximab 500 mg/m2 (Q2W) + FOLFIRI
Intervention: FOLFIRI
Outcomes
Primary Outcomes
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 Outcomes
- 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)