Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients

NCT07314294 | Recruiting Phase 2

• 1 other identifier: EMB01X204
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  Objective response rate of EMB-01 at different dose levels

  Drom the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

  Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

  Screening up to follow-up (30 days after the last dose)

Secondary Outcomes (6)

• Best Overall Response (BOR) as assessed by RECIST v1.1

  from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Cmax

  Up to 3 months after first study drug administration

• ADA

  Up to the 30-day safety follow-up visit after EOT

• Ctrough

  Through treatment completion, an average of 1 year

• Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)

  up to 3 months after first study drug administration

Study Arms (2)

EMB-01 1600 mg once weekly (QW)

EXPERIMENTAL

EMB-01 1600 mg administered once weekly throughout the study

Drug: EMB-01 1600 mg administered once weekly throughout the study

EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W)

EXPERIMENTAL

EMB-01 1600 mg once weekly for the first 6 weeks, then 1600 mg every 2 weeks thereafter

Drug: EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter

Interventions

EMB-01 1600 mg administered once weekly throughout the study DRUG

Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) throughout the study.

EMB-01 1600 mg once weekly (QW)

EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter DRUG

Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) for the first 6 weeks, followed by 1600 mg administered every 2 weeks (Q2W) thereafter.

EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to sign the informed consent form (ICF).
• Male or female aged ≥ 18 years.
• Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor from splenic flexure to rectum) with at least one measurable lesion according to RECIST v1.1.
• ECOG performance status ≤ 1.
• Willing to provide a fresh tumor biopsy sample or a stored sample obtained within the past 2 years.If no eligible archived tumor tissue sample is available and the patient's clinical condition is not suitable for biopsy, the patient may still be allowed to participate in screening upon confirmation and agreement between the investigator and the sponsor.
• Adequate organ function prior to the first study treatment.
• Prior anti-cancer treatment:
• Must have progressed on or been intolerant to at least first- or second-line systemic therapy for metastatic colorectal cancer. Prior therapy must include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, and bevacizumab with or without cetuximab. Patients should not have received TAS-102, fruquinitinib, or regorafenib.
• Any approved or investigational anti-cancer therapy (chemotherapy, immunotherapy, hormone therapy except for replacement therapy, testosterone, or oral contraceptives, biological therapy, targeted therapy) must be discontinued ≥ 4 weeks or 5 half-lives (whichever is shorter) before first study treatment.
• Local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines (e.g., tegafur, capecitabine) must be stopped ≥ 2 weeks before first study treatment; therapeutic radiopharmaceuticals must not have been administered within 8 weeks prior to the first dose of EMB-01.
• Women of childbearing potential or male patients with partners of childbearing potential must use one or more contraceptive methods from clinical screening and continue during study treatment until 3 months after the last EMB-01 dose.

You may not qualify if:

• Presence of KRAS/NRAS exon 2, 3, 4 mutations, BRAF V600 mutation, HER2 positivity (IHC3+ or amplification), RET fusion, NTRK fusion, or other molecular mutations affecting anti-EGFR or cMET efficacy(Investigator and sponsor discussion recommended if applicable), based on central lab testing or prior treatment history.
• Life expectancy \< 3 months.
• Residual adverse events (AEs) from prior anti-cancer therapy \> CTCAE grade 1.
• Primary CNS malignancy or symptomatic CNS metastases (brain, leptomeningeal, or arachnoid). Patients with asymptomatic CNS metastases may be eligible if no local radiotherapy is needed, or radiotherapy was completed ≥ 4 weeks prior to study treatment.
• Pregnant or breastfeeding women.
• Major surgery within 28 days prior to screening. Surgical wounds must be fully healed.
• Idiopathic pulmonary fibrosis, unresolved active or chronic inflammatory lung disease, or history of interstitial lung disease (ILD). Patients with resolved radiation pneumonitis may be eligible.
• History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or severe skin infections.
• Prior dual anti-EGFR and cMET therapy or bispecific antibody-drug conjugates (ADCs).
• Prior EGFR inhibitor therapy discontinued due to severe skin toxicity.
• Other significant medical conditions, psychiatric or psychological disorders, or familial/endemically high-risk diseases that may interfere with study assessments, treatment, follow-up, adherence, or increase risk of treatment-related complications.
• Any condition deemed by the investigator to make study participation not in the patient's best interest or likely to interfere, limit, or confound study assessments.

Sponsors & Collaborators

• Shanghai EpimAb Biotherapeutics Co., Ltd.: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Mingfei Zhang

CONTACT

+8618621952423; mfzhang@epimab.com

Junqiang He

CONTACT

+8618302157016; jqhe@epimab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 2, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)