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NOT YET RECRUITING
NCT07649655
PHASE1

EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, Phase Ib trial designed to evaluate the safety, tolerability, and preliminary efficacy of EMB-01 in combination with chemotherapy in patients with unresectable or metastatic colorectal cancer (CRC), and to determine the recommended Phase II combination dose (RP2CD). The study consists of a dose escalation phase followed by a dose expansion phase. Approximately 30 patients are planned to be enrolled in each combination treatment group across both phases, with a maximum total enrollment of approximately 120 patients.

Official title: A Phase Ib, Open-Label Study of EMB-01 in Combination With Chemotherapy in Patients With Unresectable or Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-07

Completion Date

2028-12-31

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

DRUG

EMB-01

EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).

DRUG

Irinotecan

Irinotecan will be administered as intravenous infusion.

DRUG

TAS-102

TAS-102 will be administered orally.

DRUG

mFOLFOX6

mFOLFOX6 will be administered as intravenous infusion.

DRUG

FOLFIRI

FOLFIRI will be administered as intravenous infusion.