A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05684211
• Other study ID #: WBP252-004
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2023
• Est. completion date: January 2023

Study information

• Verified date: January 2023
• Source: Shanghai Celfuture Biotech Co., Ltd.
• Contact: kongli Zhu, Master
• Phone: 15800363686
• Email: tsl-zukongli[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Ametumumab
A recombinant fully human anti-EGFR monoclonal antibody
• Anti-PD-1 monoclonal antibody
Toripalimab 3 mg/kg,Intravenous titration,Q2W
• Cetuximab
Cetuximab 500 mg/m2 ,Intravenous titration,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

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Celfuture Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	incidence of adverse events		Incidence and severity of AEs graded according to the NCI CTCAE v5.0, Duration of study, approximately 45 months