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 groupLocations
14China
Beijing cancer Hospital100142, BeijingBeijing Municipality, China
Nanfang Hospital510515, GuangzhouGuangdong, China
Hunan Cancer Hospital Changsha China
West China Hospital, Sichuan University Chengdu China
Sponsors and collaborators
Shanghai EpimAb Biotherapeutics Co., Ltd.
Lead sponsor
Labcorp Corporation of America Holdings, Inc
Collaborator
Source ClinicalTrials.gov