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

NCT07649655 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Unresectable/Metastatic Colorectal Cancer

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.

Sponsors & Collaborators

  • Shanghai EpimAb Biotherapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-03-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649655 on ClinicalTrials.gov