EMB-01 for Gastrointestinal Cancer

Recruiting at 13 trial locations

Overseen By Di Hu, M.Sc

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Must not be taking: Hormonal therapy, Radiopharmaceuticals

Disqualifiers: CNS malignancy, Pregnancy, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 48 months

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EMB-01 for advanced gastrointestinal cancers, such as stomach, liver, bile duct, and colorectal cancers. The goal is to determine if EMB-01 is safe and effective against these difficult-to-treat cases. Individuals with these cancers who have exhausted all standard treatments without success might be suitable candidates. Participants must have measurable disease and agree to provide a tumor or blood sample for testing. As a Phase 1 trial, this research aims to understand how EMB-01 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any anticancer drugs, including chemotherapy, immune therapy, and targeted therapies, at least 4 weeks or within 5 half-lives (whichever is shorter) before starting the trial medication. Hormone-replacement therapy, testosterone, or oral contraceptives are exceptions and do not need to be stopped.

Is there any evidence suggesting that EMB-01 is likely to be safe for humans?

Research shows that EMB-01, a special type of antibody, has been tested for safety in people with advanced cancers. In earlier studies, patients with advanced colorectal cancer generally tolerated EMB-01 well. Some patients experienced side effects, mostly mild to moderate, while serious side effects were less common.

Since this trial is in its early stages, the drug has been deemed safe enough for further testing. This usually indicates that earlier tests showed some promise regarding safety. If you decide to join a trial, healthcare professionals will closely monitor you to manage any side effects that might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gastrointestinal cancer?

Unlike the standard care for gastrointestinal cancers, which typically includes chemotherapy, targeted therapy, and immunotherapy, EMB-01 is unique because it uses a bispecific antibody approach. This means it can bind to two different targets simultaneously, potentially enhancing its effectiveness against cancer cells. Researchers are excited about EMB-01 because this dual-targeting mechanism may improve precision in attacking cancer cells and could lead to better outcomes for patients with advanced or metastatic gastrointestinal cancers.

What evidence suggests that EMB-01 might be an effective treatment for gastrointestinal cancer?

Research has shown that EMB-01, a special type of antibody, offers promising results in treating certain cancers. In previous studies, EMB-01 proved effective for patients with metastatic colorectal cancer who had already tried other treatments. This trial will evaluate EMB-01 as a potential option for people with advanced gastrointestinal cancers. The drug targets two important proteins, EGFR and cMET, which often aid cancer growth. By blocking these proteins, EMB-01 may help slow down or stop the cancer from worsening. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced/metastatic gastrointestinal cancers who've tried all standard treatments without success. They must have certain genetic markers in their tumors or blood, good organ function, and an ECOG score ≤1. Women of childbearing age and men with partners of childbearing age must use contraception.

Inclusion Criteria

I will provide a blood sample for genetic testing but not a tumor sample.

The participant must: - Be able to understand and sign the Informed Consent Form - Have confirmed advanced/metastatic stomach, liver, bile duct, or colorectal cancer with measurable disease - Have already tried standard treatments without success - Have tissue samples available for testing - Have good organ function - Have an ECOG score of 0 or 1 - Use contraception if they or their partner can conceive, during the study and for 3 months after treatment.

My cancer shows specific genetic changes related to cMET or EGFR.

Exclusion Criteria

Here are the screening exclusion criteria in simpler terms: - You are not expected to live longer than 3 months. - You have a type of cancer or certain symptoms related to the brain and spinal cord. - You are pregnant or breastfeeding. - You had a major surgery within the last 28 days. - You have other serious medical, psychiatric, or family conditions that could affect treatment or put you at risk for complications.

I am willing to sign the consent form and my cancer does not have gene changes resistant to treatment.

Timeline for a Trial Participant

Molecular Prescreening

Participants are prescreened for cMET and EGFR genetic alterations and protein expression

2-4 weeks

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EMB-01 for advanced/metastatic gastrointestinal cancers

up to 48 months

Safety Follow-up

Participants are monitored for safety after treatment completion

30 days

Disease Progression Follow-up

Participants are monitored for disease progression after treatment

up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

• EMB-01

Trial Overview The study tests the safety and effectiveness of a new treatment called EMB-01 on various gastrointestinal cancers like gastric cancer, liver cancer (hepatocellular), bile duct cancer (cholangiocarcinoma), and colorectal cancer.

How Is the Trial Designed?

Group I: Phase Ib and Phase II Experimental Treatment 1 Intervention

The study will consist of Phase Ib and Phase II. The study is planning to recruit approximately 152 patients in total for advanced/metastatic GI cancers, which include 24 patients in Phase Ib and up to approximately 128 patients in Phase II. For GC, HCC, and BTC groups, up to approximately 24 patients may be enrolled in Phase Ib and Phase II. For CRC group, up to approximately 80 patients may be enrolled in Phase Ib and Phase II with up to 40 patients in each subgroup.

Who Is Running the Clinical Trial?

Shanghai EpimAb Biotherapeutics Co., Ltd.

Lead Sponsor

Trials

6

Recruited

600+

Labcorp Drug Development, Inc.

Industry Sponsor

Trials

11

Recruited

540+

Labcorp Drug Development Inc

Industry Sponsor

Trials

17

Recruited

2,100+

Labcorp Corporation of America Holdings, Inc

Industry Sponsor

Trials

22

Recruited

3,600+

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT168/761483/Abstract-CT168-EMB-01-an-EGFR-cMET-bispecific

Abstract CT168: EMB-01, an EGFR/cMET bispecific antibody ... EMB-01 demonstrated promising efficacy in heavily pretreated mCRC, including those with prior progression on anti-EGFR, with an acceptable ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04930432

Study of MCLA-129, a Human Bispecific EGFR and cMet ... This is a multicenter, open-label, single-agent phase I/II clinical study of MCLA-129 in patients with advanced solid tumors to evaluate the safety, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11512917/

Clinical Progresses and Challenges of Bispecific ... The effectiveness of immunotherapies varies widely, influenced by factors related to the patient, the tumor, or the specific treatment ...

4. nature.com nature.com/articles/s41416-025-02990-x

First-in-human phase I study of EMB-02, a bispecific ... EMB-02 is a symmetric bispecific antibody targeting programmed cell death protein-1 and lymphocyte-activation gene 3 simultaneously.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7333932/

Anti-EGFR therapy in metastatic colorectal cancer Data from 185 countries have shown that >1.8 million new CRC cases and 881,000 deaths were estimated to have occurred in 2018 and the incidence ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05176665/emb-01-in-patients-with-advanced-metastatic-gastrointestinal-cancers

EMB-01 in Patients With Advanced/Metastatic ... This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, ...

7. peearz.com peearz.com/trialsindex?nctid=NCT05176665

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal ... This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular ...