EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (NCT05176665) | Clinical Trial Compass
RecruitingPhase 1/2
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
United States, China152 participantsStarted 2021-10-21
Plain-language summary
This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. 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). To be eligible, patients must meet following criteria:
. Have failed all standard of care therapies known to confer clinical benefit. Patients who is not tolerable on standard of care therapies, or no standard of care therapies available, or refused standard of care therapies are eligible.
. Have measurable disease as defined by RESIST v 1.1.
Exclusion criteria
. Patients who are unwilling to sign the molecular pre-screening ICF.
. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Timeframe: Phase 1b, screening up to follow-up (30 days after the last dose)
2
Best Overall Response (BOR) as assessed by RECIST v1.1
Timeframe: Phase II, 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
3
Objective Response Rate (ORR) as assessed by RECIST v1.1
Timeframe: Phase II, 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
4
Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1
Timeframe: Phase II, 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
5
Disease Control Rate (DCR) as assess by RECIST v1.1
Timeframe: Phase II, 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
. Patients with a documented gene alteration including but not limited to HER2, KRAS, NRAS, BRAF, NTRK, ALK, RET, ROS1, and FGFR, etc. that is known to confer resistance to EGFR and/or cMET inhibitors.\* \* In Phase II, CRC patients with activated KRAS, NRAS or BRAF mutation should be excluded, but patients with other gene alterations do not need to be excluded.
. Life expectancy \< 3 months.
. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNS metastases are eligible.
. Pregnant or nursing females.
. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.
. Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Progression-Free Survival (PFS) as assess by RECIST v1.1
Timeframe: Phase II, 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
7
Maximum serum concentration (Cmax) of EMB-01
Timeframe: Phase Ib only, up to 3 months after first study drug administration
8
Trough serum concentration (Ctrough) of EMB-01
Timeframe: Phase Ib only, predose, through treatment completion, an average of 1 year
9
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
10
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
11
Elimination half-life (T1/2)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
12
Systemic clearance (CL)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
13
Apparent volume of distribution at steady-state (Vss)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
14
Accumulation Ratio (AR) after multiple dosing
Timeframe: Phase Ib only, up to 3 months after first study drug administration
15
Incidence of positive ADA
Timeframe: Phase Ib only, up to the 30-day safety follow-up visit after EOT
16
Clinical benefit rate(CBR) as assess by RECIST v1.1
Timeframe: Phase II, 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