EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai EpimAb Biotherapeutics Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
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.
Trial design
Design model
Single group
Treatments tested in this trial
EMB-01
DrugEMB-01 at the RP2D of 1600 mg will be administered as an IV infusion once weekly (QW) throughout the study. One cycle is defined as 4 weeks (4 doses).
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: Phase Ib and Phase IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Time frame
Phase 1b, screening up to follow-up (30 days after the last dose)2
Best Overall Response (BOR) as assessed by RECIST v1.1
Best Overall Response (BOR) as assessed by RECIST v1.1
Time frame
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 months3
Objective Response Rate (ORR) as assessed by RECIST v1.1
Objective Response Rate (ORR) as assessed by RECIST v1.1
Time frame
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 months4
Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1
Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1
Time frame
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 monthsSecondary outcomes
1
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Time frame
Phase II, screening up to follow-up (30 days after the last dose)2
Maximum serum concentration (Cmax) of EMB-01
Maximum serum concentration (Cmax) of EMB-01
Time frame
Phase II, up to 3 months after first study drug administration3
Trough serum concentration (Ctrough) of EMB-01
Trough serum concentration (Ctrough) of EMB-01
Time frame
Phase II, predose, through treatment completion, an average of 1 year4
Incidence of positive ADA
Incidence of positive ADA
Time frame
Phase II , up to the 30-day safety follow-up visit after EOTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai EpimAb Biotherapeutics Co., Ltd.
Lead sponsor
Labcorp Corporation of America Holdings, Inc
Collaborator
Source ClinicalTrials.gov