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

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-01-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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;

Group Type: ACTIVE_COMPARATOR

Ametumumab

Intervention Type: DRUG

A recombinant fully human anti-EGFR monoclonal antibody

Anti-PD-1 monoclonal antibody

Intervention Type: DRUG

Toripalimab 3 mg/kg，Intravenous titration，Q2W

FOLFIRI

Intervention Type: DRUG

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

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;

Group Type: ACTIVE_COMPARATOR

Ametumumab

Intervention Type: DRUG

A recombinant fully human anti-EGFR monoclonal antibody

Anti-PD-1 monoclonal antibody

Intervention Type: DRUG

Toripalimab 3 mg/kg，Intravenous titration，Q2W

FOLFIRI

Intervention Type: DRUG

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

Ametumumab (Q2W) + FOLFIRI;

Ametumumab 450 mg/m2 (Q2W) + FOLFIRI

Group Type: ACTIVE_COMPARATOR

Ametumumab

Intervention Type: DRUG

A recombinant fully human anti-EGFR monoclonal antibody

FOLFIRI

Intervention Type: DRUG

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

Cetuximab + FOLFIRI;

Cetuximab 500 mg/m2 (Q2W) + FOLFIRI

Group Type: ACTIVE_COMPARATOR

Cetuximab

Intervention Type: DRUG

Cetuximab 500 mg/m2 ，Intravenous titration，Q2W

FOLFIRI

Intervention Type: DRUG

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

Interventions

Ametumumab

A recombinant fully human anti-EGFR monoclonal antibody

Intervention Type: DRUG

Anti-PD-1 monoclonal antibody

Toripalimab 3 mg/kg，Intravenous titration，Q2W

Intervention Type: DRUG

Cetuximab

Cetuximab 500 mg/m2 ，Intravenous titration，Q2W

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Celfuture Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

kongli Zhu, Master

Role: CONTACT

tsl-zukongli@tasly.com

15800363686

Facility Contacts

Hongming Pan, MD

Role: primary

panhongming@zju.edu.cn

13605716662

Other Identifiers

WBP252-004

Identifier Type: -

Identifier Source: org_study_id