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

NCT05684211 | Unknown Phase 2

• 1 other identifier: WBP252-004
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (4)

Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI

ACTIVE COMPARATOR

Ametumumab 450 mg/m2 (QW) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;

Drug: Ametumumab; Drug: Anti-PD-1 monoclonal antibody; Drug: FOLFIRI

Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;

ACTIVE COMPARATOR

Ametumumab 450 mg/m2 (Q2W) + anti-PD-1 monoclonal antibody (in the case of toripalimab 3 mg/kg, Q2W) + FOLFIRI;

Drug: Ametumumab; Drug: Anti-PD-1 monoclonal antibody; Drug: FOLFIRI

Ametumumab (Q2W) + FOLFIRI;

ACTIVE COMPARATOR

Ametumumab 450 mg/m2 (Q2W) + FOLFIRI

Drug: Ametumumab; Drug: FOLFIRI

Cetuximab + FOLFIRI;

ACTIVE COMPARATOR

Cetuximab 500 mg/m2 (Q2W) + FOLFIRI

Drug: Cetuximab; Drug: FOLFIRI

Interventions

Ametumumab DRUG

A recombinant fully human anti-EGFR monoclonal antibody

Ametumumab (Q2W) + FOLFIRI;; Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI; Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;

Anti-PD-1 monoclonal antibody DRUG

Toripalimab 3 mg/kg，Intravenous titration，Q2W

Ametumumab (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI; Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;

Cetuximab DRUG

Cetuximab 500 mg/m2 ，Intravenous titration，Q2W

Cetuximab + FOLFIRI;

FOLFIRI 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 (QW) + anti-PD-1 monoclonal antibody+ FOLFIRI; Ametumumab(Q2W) + anti-PD-1 monoclonal antibody + FOLFIRI;; Cetuximab + FOLFIRI;

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Celfuture Biotech Co., Ltd.: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

spartalizumab; Cetuximab; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

kongli Zhu, Master

CONTACT

15800363686; tsl-zukongli@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

CN (1)