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

Shanghai Celfuture Biotech

Status and phase: Not yet enrolling; Phase 2

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05684211

WBP252-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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84 participants in 4 patient groups

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

Active Comparator group

Description:

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

Treatment:

Drug: Anti-PD-1 monoclonal antibody

Drug: Ametumumab

Drug: FOLFIRI

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

Active Comparator group

Description:

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

Treatment:

Drug: Anti-PD-1 monoclonal antibody

Drug: Ametumumab

Drug: FOLFIRI

Ametumumab (Q2W) + FOLFIRI;

Active Comparator group

Description:

Ametumumab 450 mg/m2 (Q2W) + FOLFIRI

Treatment:

Drug: Ametumumab

Drug: FOLFIRI

Cetuximab + FOLFIRI;

Active Comparator group

Description:

Cetuximab 500 mg/m2 (Q2W) + FOLFIRI

Treatment:

Drug: Cetuximab

Drug: FOLFIRI