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

Program Status

Not yet recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Ametumumab

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Trial only in China. For patients who are about to receive first line for metastatic CRC.
The study compares:
ametumumab (an anti-EGFR monoclonal antibody) in combination with anti-PD-1 monoclonal antibody (immunotherapy) and FOLFIRI (chemotherapy
versus
ametumumab or cetuximab (anti-EGFR monoclonal antibody) in combination with FOLFIRI  (standard of care).
Only for patients RAS wild (no KRAS or NRAS mutations) and BRAF wild (no mutated).

Location Location Status
China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310000
Not yet recruiting

Contacts

kongli Zhu, Master
Contact
15800363686 tsl-zukongli@tasly.com

Inclusion 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

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.

NCT ID

NCT05684211

Date Trial Added

2023-01-13

Updated Date

2023-02-01