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

June 10, 2026 updated by: Shanghai EpimAb Biotherapeutics Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Male or female patients aged ≥ 18 and < 75 years. 2. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor located from the splenic flexure to the rectum), with measurable disease per RECIST v1.1.

    3. ECOG performance status ≤ 1. 4. Agrees to provide archival tumor tissue (formalin-fixed paraffin-embedded, collected within 18 months) or newly obtained biopsy tissue. If no eligible archival tissue is available and the patient's clinical condition is not suitable for biopsy, the patient may be screened after confirmation and agreement between the investigator and sponsor.

    5. Adequate organ function within 14 days prior to the first dose of study treatment 6. Prior anti-tumor therapy:

    1. Patients who received any approved or investigational anti-cancer therapy must have discontinued such therapy at least 4 weeks prior to the first dose of study treatment or 5 half-lives of the agent, whichever is shorter.

    2. Patients who received local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines must have discontinued such therapy at least 2 weeks prior to the first dose of study treatment. No therapeutic radiopharmaceuticals within 8 weeks prior to the first dose of EMB-01.

      Prior anti-tumor therapy requirements by combination regimen*:

  • Arm A (irinotecan) and Arm B (TAS-102): Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, plus prior anti-VEGF therapy (with or without anti-EGFR therapy), with disease progression or intolerance; no prior TAS-102/fruquintinib/regorafenib. If prior anti-EGFR therapy was received, the patient must have achieved CR, PR, or SD, with the last anti-EGFR dose administered at least 4 months prior to the first study drug dose.
  • Arm C (mFOLFOX6): No prior oxaliplatin-based chemotherapy and no prior anti-EGFR therapy.

  • Arm D (FOLFIRI): No prior irinotecan-based chemotherapy and no prior anti-EGFR therapy.

    7. Female patients of childbearing potential or male patients with partners of childbearing potential must use one or more contraceptive methods from the screening period, continue such methods during study treatment, and until 3 months after the last dose of EMB-01 (for Arm B: 6 months after last TAS-102 dose for both sexes; for Arm C: 9 months after last oxaliplatin dose for females, 6 months for males; for Arm A/D: 6 months after last chemotherapy dose for females, 3 months for males).

    8. Able to swallow and retain oral medications, and has adequate venous access.

Exclusion Criteria:

  • 1. Expected survival < 3 months. 2. Presence of KRAS/NRAS (exons 2, 3, 4), BRAF V600, HER2 positivity (IHC3+ and/or amplification), RET/NTRK fusion, or other molecular alterations that may affect anti-EGFR or cMET therapy efficacy, as detected by central laboratory testing at screening or documented in prior treatment history. (Discussion between investigator and sponsor in writing is recommended if applicable.) 3. Persistent adverse events (AEs) from prior anti-tumor therapy > Grade 2 per CTCAE v5.0, except alopecia, Grade 2 fatigue, or Grade 2 peripheral neuropathy.

    4. Primary central nervous system (CNS) malignancy or symptomatic CNS/leptomeningeal metastases. Asymptomatic CNS metastases are allowed if no local radiotherapy is required, or if radiotherapy was completed ≥ 4 weeks prior to first study dose.

    5. Prior treatment with anti-EGFR × cMET bispecific antibody or bispecific ADC. 6. Discontinuation of EGFR inhibitors due to skin toxicity. 7. History of life-threatening hypersensitivity, or known allergy to recombinant proteins/excipients in EMB-01 or any study treatment contraindication.

    8. Systemic corticosteroids (> 10 mg prednisone equivalent/day) or other immunosuppressants required within 14 days prior to first dose, regardless of autoimmune disease. Inhaled/topical/ocular/nasal/joint steroids are permitted; adrenal replacement steroids are allowed at >10 mg/day if no active autoimmune disease.

    9. Severe/uncontrolled cardiac disease requiring treatment 10. Use or planned use of QT-prolonging or rhabdomyolysis-inducing drugs during screening through study end (only Arm C); or known CYP3A4/UGT1A1 strong inhibitors/CYP3A4 inducers/anticholinesterase neuromuscular blockers (only Arms A/D).

    10. Rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (only Arm B).

    11. Other serious uncontrolled medical, psychiatric, or familial/endemic conditions that may interfere with study assessments, adherence, or safety (investigator's assessment).

    12. Any condition that, in the investigator's opinion, makes study participation not in the patient's best interest or confounds study evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
EMB-01 + Irinotecan
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.
Experimental: Arm B
EMB-01 + TAS-102
Drug: EMB-01
EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).
Drug: TAS-102
TAS-102 will be administered orally.
Experimental: Arm C
EMB-01 + 5-Flurouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)
Drug: EMB-01
EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).
Drug: mFOLFOX6
mFOLFOX6 will be administered as intravenous infusion.
Experimental: Arm D
EMB-01 + 5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)
Drug: EMB-01
EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).
Drug: FOLFIRI
FOLFIRI will be administered as intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events (AEs)
Time Frame: From enrollment up to 30 days after last dose of study treatment
Safety profile of EMB-01 in combination with chemotherapy will be evaluated by the incidence, severity, seriousness, and relationship of AEs, graded per CTCAE v5.0
From enrollment up to 30 days after last dose of study treatment
Incidence of dose-limiting toxicities (DLTs)
Time Frame: Up to Cycle 1 (28 days)
DLTs will be assessed according to protocol-defined criteria during the first treatment cycle of EMB-01 in combination with chemotherapy regimens
Up to Cycle 1 (28 days)
Tolerability of EMB-01 in combination with chemotherapy
Time Frame: From first dose to 30 days after last dose, up to 2 years
Outcome Measure: Treatment interruption due to intolerability and relative dose intensity (RDI)
From first dose to 30 days after last dose, up to 2 years
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2CD)
Time Frame: Through study completion, up to 2 years
Determination of the MTD and/or RP2CD of EMB-01 in combination with chemotherapy
Through study completion, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Ctrough
Time Frame: Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
Objective response rate (ORR)
Time Frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years.
defined as the proportion of participants achieving CR or PR per RECIST v1.1
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years.
Disease control rate (DCR)
Time Frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
defined as the proportion of participants achieving CR, PR, or SD per RECIST v1.1
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Best Overall Response (BOR)
Time Frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
defined as the best response achieved at any time during study treatment, per RECIST v1.1, categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Duration of Response (DOR)
Time Frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
defined as the time from the first documentation of objective response (CR or PR per RECIST v1.1) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Clinical Benefit Rate (CBR)
Time Frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
defined as the proportion of participants achieving CR, PR, or durable SD (≥ 6 months) per RECIST v1.1.
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Progression-Free Survival (PFS)
Time Frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
defined as the time from the first study treatment dose to the first documentation of progressive disease (PD per RECIST v1.1) or death due to any cause, whichever occurs first.
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Incidence anti-drug antibodies (ADAs)
Time Frame: From C1D1 pre-dose until 30 days after last dose, up to 2 years
Incidence and titer of ADAs against EMB-01 when administered in combination with chemotherapy
From C1D1 pre-dose until 30 days after last dose, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMB01X203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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