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.
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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)
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
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
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
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
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
Maximum serum concentration (Cmax) of EMB-01
Timeframe: Phase Ib only, up to 3 months after first study drug administration
Trough serum concentration (Ctrough) of EMB-01
Timeframe: Phase Ib only, predose, through treatment completion, an average of 1 year
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
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
Elimination half-life (T1/2)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
Systemic clearance (CL)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
Apparent volume of distribution at steady-state (Vss)
Timeframe: Phase Ib only, up to 3 months after first study drug administration
Accumulation Ratio (AR) after multiple dosing
Timeframe: Phase Ib only, up to 3 months after first study drug administration
Incidence of positive ADA
Timeframe: Phase Ib only, up to the 30-day safety follow-up visit after EOT
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