Study of EMB-01 for Advanced Gastrointestinal Cancers
This study is testing a drug called EMB-01 for people with advanced or metastatic (spread to other parts of the body) gastrointestinal cancers, including stomach, liver, bile duct, and colorectal cancers. The main goals are to see how safe EMB-01 is and how well it shrinks tumors. To join, your cancer must show specific changes in certain genes (EGFR or cMET) or proteins. Researchers will look for side effects and measure how much tumors shrink or disappear. The study plans to enroll 152 participants.
- Study design
- This is an open-label, multi-stage study (meaning you and your doctors will know you are receiving EMB-01) that includes a Phase Ib and Phase II part. It aims to enroll 152 participants.
- What's involved
- You would receive EMB-01 as an intravenous (IV) infusion once a week. One cycle of treatment is 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for safety for 30 days after your last dose. Tumor response will be assessed for up to 48 months from the start of dosing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
At a glance
Conditions
Where it's being run
14 sites across 4 statesWho to contact
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What this trial measures
- Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0Phase 1b, screening up to follow-up (30 days after the last dose)
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
- Best Overall Response (BOR) as assessed by RECIST v1.1Phase 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
Best Overall Response (BOR) as assessed by RECIST v1.1
- Objective Response Rate (ORR) as assessed by RECIST v1.1Phase 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
Objective Response Rate (ORR) as assessed by RECIST v1.1
- Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1Phase 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
Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1
- Disease Control Rate (DCR) as assess by RECIST v1.1Phase 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
Disease Control Rate (DCR) as assess by RECIST v1.1
- Progression-Free Survival (PFS) as assess by RECIST v1.1Phase 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
Progression-Free Survival (PFS) as assess by RECIST v1.1
- Maximum serum concentration (Cmax) of EMB-01Phase Ib only, up to 3 months after first study drug administration
Maximum serum concentration (Cmax) of EMB-01
- Trough serum concentration (Ctrough) of EMB-01Phase Ib only, predose, through treatment completion, an average of 1 year
Trough serum concentration (Ctrough) of EMB-01
- Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)Phase Ib only, up to 3 months after first study drug administration
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
- Area under the concentration-time curve from time 0 to infinity (AUC0-inf)Phase Ib only, up to 3 months after first study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
- Elimination half-life (T1/2)Phase Ib only, up to 3 months after first study drug administration
Elimination half-life (T1/2)
- Systemic clearance (CL)Phase Ib only, up to 3 months after first study drug administration
Systemic clearance (CL)
- Apparent volume of distribution at steady-state (Vss)Phase Ib only, up to 3 months after first study drug administration
Apparent volume of distribution at steady-state (Vss)
- Accumulation Ratio (AR) after multiple dosingPhase Ib only, up to 3 months after first study drug administration
Accumulation Ratio (AR) after multiple dosing
- Incidence of positive ADAPhase Ib only, up to the 30-day safety follow-up visit after EOT
Incidence of positive ADA
- Clinical benefit rate(CBR) as assess by RECIST v1.1Phase 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
Clinical benefit rate(CBR) as assess by RECIST v1.1