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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
Study Summary
This trial is testing a new drug, EMB-01, to see if it is safe and effective against advanced gastrointestinal cancers including stomach, liver, bile duct, and colon cancers.
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Labcorp Drug Development, Inc.Industry Sponsor
10 Previous Clinical Trials
385 Total Patients Enrolled
Labcorp Drug Development IncIndustry Sponsor
16 Previous Clinical Trials
3,034 Total Patients Enrolled
Shanghai EpimAb Biotherapeutics Co., Ltd.Lead Sponsor
5 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ib and Phase II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings remaining for this clinical research project?
"According to the information hosted on clinicaltrials.gov, this experiment is actively recruiting for participants having first been published on October 21st 2021 and most recently modified on April 12th 2022."
Answered by AI
What are the primary aims of this medical study?
"The principal purpose of the Labcorp Drug Development, Inc. study is to assess Systemic clearance (CL) over a 3 month period following initial drug administration. Additionally, researchers will be measuring secondary metrics such as Duration of Response (DoR), Maximum serum concentration (Cmax) of EMB-01, and Progression-Free Survival (PFS)."
Answered by AI
Are there any other experiments that have assessed the efficacy of EMB-01?
"Initially trialed at Dana-Farber Cancer Institute in 2018, EMB-01 has 0 completed studies and 2 active trials. Notably, a great portion of these are located within Houston, TX."
Answered by AI
What is the scope of enrolment in this clinical trial?
"Affirmative. Clinicaltrials.gov reveals that this clinical investigation is still in the recruiting phase, having first been posted on October 21st 2021 and last edited on April 12th 2022. A total of 96 patients need to be recruited between two locations."
Answered by AI
Has this research endeavor been attempted before?
"EMB-01 is a drug that has been under research for 3 years. A 186 subject trial sponsored by Shanghai EpimAb Biotherapeutics Co., Ltd. was conducted in 2018, which lead to Phase 1 & 2 approval of the substance. Currently, two active trials are taking place across 8 cities and two countries."
Answered by AI
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