Phase Ib/II, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Shanghai EpimAb Biotherapeutics Co., Ltd.
Summary
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.
Description
This is an open-label, Phase Ib/II, multi-stage study of EMB-01 in patients with advanced gastrointestinal tumors including gastric cancer, hepatocellular cancer, cholangiocarcinoma cancer and colorectal cancer, who have EGFR/cMET gene alterations or protein over expression and progressed on available standard therapies and for whom no standard therapy exists that would confer clinical benefit. All patients will be prescreened for cMET and EGFR genetic alterations and protein expression. Only those who met the molecular pre-screening criteria will proceed to clinical screening to determine the…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Molecular Pre-screening Inclusion criteria 1. cMET amplification in tumor sample; OR 2. cMET overexpression in tumor sample; OR 3. EGFR overexpression in tumor sample; OR 4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA). In Phase II, CRC patients must provide blood sample for NGS test, but may not provide tumor samples at prescreening visit. CRC patients don't need to meet the above criteria of EGFR/cMET amplification, overexpression or gene aberration. Screening Inclusion Criteria 1. Able to understand and willing to sign the Inform…
Interventions
- DrugEMB-01
EMB-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).
Locations (14)
- MD Anderson Cancer CenterHouston, Texas
- Beijing cancer HospitalBeijing, Beijing Municipality
- Nanfang HospitalGuangzhou, Guangdong
- Hunan Cancer HospitalChangsha
- West China Hospital, Sichuan UniversityChengdu
- The Sixth Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou