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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

2026-09-30

Completion Date

2028-12-31

Last Updated

2026-10-16

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.

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China