What side effects are associated with this type of intervention?

Common side effects of treatments targeting EGFR and c-MET, such as bispecific antibodies like EMB-01, include skin toxicities (e.g., rash), diarrhea, fatigue, gastrointestinal issues, liver enzyme abnormalities, and edema. These side effects are generally manageable but require monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several drugs targeting EGFR and c-MET for the treatment of various tumors. For instance, cetuximab and panitumumab are monoclonal antibodies targeting EGFR, approved for metastatic colorectal cancer. Crizotinib, a c-MET inhibitor, is approved for non-small cell lung cancer with specific mutations. Additionally, bispecific antibodies like blinatumomab, targeting CD19 and CD3, have been approved for certain types of leukemia, showcasing the potential of bispecific antibodies in cancer treatment. These approvals highlight the evolving landscape of targeted therapies and the promise of bispecific antibodies like EMB-01 in treating advanced cancers.

What other types of research exist?

Promising alternatives to EMB-01 for tumor patients include: 1) Pembrolizumab (anti-PD-1 therapy) which has shown efficacy in various cancers including non-small cell lung cancer and head and neck cancer. 2) Cabozantinib (tyrosine kinase inhibitor) which has been effective in medullary thyroid cancer and other solid tumors. 3) Nivolumab (anti-PD-1 therapy) which has demonstrated benefits in lung cancer and head and neck cancer. 4) Atezolizumab (anti-PD-L1 therapy) which is used in combination with chemotherapy for non-small cell lung cancer. These therapies have shown significant antitumor activity and are likely to be relevant treatment options in 2024.

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Unknown

EMB-01 for Gastrointestinal Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Screening Inclusion Criteria: Able to understand and willing to sign the Informed Consent Form (ICF). Histologically/cytologically confirmed advanced/metastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). Have failed all standard of care therapies known to confer clinical benefit. Have measurable disease as defined by RESIST v 1.1. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit. Must have adequate organ function. ECOG score ≤1. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.

Molecular Pre-screening Inclusion criteria (Phase II only): cMET amplification in tumor sample; OR cMET overexpression in tumor sample; OR EGFR overexpression in tumor sample; OR Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase ii, predose, through treatment completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones for anticancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, hair loss, diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase ii, predose, through treatment completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase ii, predose, through treatment completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase ii, predose, through treatment completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accumulation Ratio (AR) after multiple dosing

Apparent volume of distribution at steady-state (Vss)

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

+3 more

Secondary study objectives

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

Clinical benefit rate(CBR) as assess by RECIST v1.1

Disease Control Rate (DCR) as assess by RECIST v1.1

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase Ib and Phase IIExperimental Treatment1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for tumors often involve targeting specific pathways that are crucial for tumor growth and survival. Bispecific antibodies, like EMB-01, simultaneously target two different antigens, in this case, EGFR and c-MET. EGFR is involved in cell proliferation and survival, while c-MET plays a role in cell growth, motility, and differentiation. By inhibiting both pathways, bispecific antibodies can more effectively disrupt the tumor's ability to grow and spread. This dual-targeting approach is significant for tumor patients as it can potentially lead to better treatment outcomes by addressing multiple mechanisms that tumors use to thrive.