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
Qualifiers
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
Treatments tested in this trial
- EMB-01
Treatment groups
152 Participants
are divided into 1 treatment groupSponsors and collaborators
Shanghai EpimAb Biotherapeutics Co., Ltd.
Lead sponsor
Labcorp Corporation of America Holdings, Inc
Collaborator
Source ClinicalTrials.gov