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

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called EMB-01 for patients with advanced digestive system cancers who haven't responded to other treatments. The drug works by targeting specific genetic changes in the cancer cells to stop their growth.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+