Actively Recruiting
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Led by Shanghai EpimAb Biotherapeutics Co., Ltd. · Updated on 2024-08-26
152
Participants Needed
14
Research Sites
218 weeks
Total Duration
On this page
Sponsors
S
Shanghai EpimAb Biotherapeutics Co., Ltd.
Lead Sponsor
L
Labcorp Corporation of America Holdings, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- cMET amplification or overexpression in tumor sample, or EGFR overexpression in tumor sample, or other EGFR or cMET gene alteration in blood sample
- For Phase II colorectal cancer patients, blood sample for NGS test is required; tumor samples may not be needed
- Ability to understand and sign the informed consent form
- Histologically or cytologically confirmed advanced/metastatic gastric, hepatocellular, biliary tract, or colorectal cancer with measurable disease
- Failed all standard therapies known to provide clinical benefit, or intolerant to them, or no standard therapy available, or refused standard therapies
- Archival tumor tissue collected within 1 year or new biopsy at molecular prescreening
- Adequate organ function
- Prior anticancer drugs stopped at least 4 weeks or within 5 half-lives before first EMB-01 dose
- Local radiotherapy stopped at least 2 weeks before first EMB-01 dose; no therapeutic radiopharmaceuticals within 8 weeks
- Prior targeted therapies stopped at least 4 weeks or within 5 half-lives before first EMB-01 dose
- Use of effective contraception for patients with fertility starting from screening and throughout treatment plus 3 months
- ECOG performance status score of 1 or less
You will not qualify if you...
- Unwillingness to sign molecular prescreening informed consent
- Central lab results not meeting molecular prescreening criteria
- Gene alterations known to cause resistance to EGFR or cMET inhibitors, including HER2, KRAS, NRAS, BRAF, NTRK, ALK, RET, ROS1, FGFR
- For Phase II colorectal cancer patients, activated KRAS, NRAS, or BRAF mutations
- Life expectancy less than 3 months
- Primary central nervous system cancer or symptomatic brain/leptomeningeal metastases; asymptomatic CNS metastases allowed
- Pregnant or nursing females
- Major surgery within 28 days before screening; surgical wounds not fully healed
- Serious uncontrolled medical conditions such as uncontrolled diabetes, active infections, active gastric ulcers, uncontrolled seizures, cerebrovascular incidents, GI bleeding, severe clotting or cardiac disorders
- Psychiatric, psychological, family, or geographical conditions that may interfere with treatment, follow-up, compliance, or increase risk of complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Beijing cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Actively Recruiting
4
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
5
West China Hospital, Sichuan University
Chengdu, China
Actively Recruiting
6
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China
Actively Recruiting
7
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
8
Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
9
Shandong Cancer Hospital
Jinan, China
Actively Recruiting
10
Gansu Provincial Hospital
Lanzhou, China
Actively Recruiting
11
The Affiliated hospital of Qingdao University
Qingdao, China
Not Yet Recruiting
12
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
13
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
14
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
R
Rong Wang, M.Sc
CONTACT
D
Di Hu, M.Sc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here