Phase Ib/II, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Who is this study for? Patients with Gastrointestinal Cancers
What treatments are being studied? EMB-01
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Molecular Pre-screening Inclusion criteria

• 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).

∙ 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

• Able to understand and willing to sign the Informed Consent Form (ICF).

• Histologically/cytologically confirmed advanced/metastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). To be eligible, patients must meet following criteria:

‣ Have failed all standard of care therapies known to confer clinical benefit. Patients who is not tolerable on standard of care therapies, or no standard of care therapies available, or refused standard of care therapies are eligible.

⁃ Have measurable disease as defined by RESIST v 1.1.

• Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.

• Must have adequate organ function.

• Regarding prior anti-tumor therapy:

‣ Patients who have received any anticancer drugs approved or investigational, including chemotherapy, immune therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, must have stopped treatment at least 4 weeks or within 5 half -lives whichever shorter before first dose of EMB-01.

⁃ Local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.

⁃ Patients who have received prior targeted therapies must have stopped treatment for at least 4 weeks or within 5 half-lives, whichever is shorter before first dose of EMB-01.

• Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.

• ECOG score ≤1.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
China
Beijing cancer Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Nanfang Hospital
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Shandong Cancer Hospital
RECRUITING
Jinan
Gansu Provincial Hospital
RECRUITING
Lanzhou
The Affiliated hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Rong Wang, M.Sc
CT.info@epimab.com
+86-21-61043299
Backup
Di Hu, M.Sc
CT.info@epimab.com
+862161043299
Time Frame
Start Date: 2021-10-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 152
Treatments
Experimental: Phase Ib and Phase II
The study will consist of Phase Ib and Phase II. The study is planning to recruit approximately 152 patients in total for advanced/metastatic GI cancers, which include 24 patients in Phase Ib and up to approximately 128 patients in Phase II. For GC, HCC, and BTC groups, up to approximately 24 patients may be enrolled in Phase Ib and Phase II. For CRC group, up to approximately 80 patients may be enrolled in Phase Ib and Phase II with up to 40 patients in each subgroup.
Sponsors
Collaborators: Labcorp Corporation of America Holdings, Inc
Leads: Shanghai EpimAb Biotherapeutics Co., Ltd.

This content was sourced from clinicaltrials.gov