EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Recruiting now · Phase 1/Phase 2

Conditions studied: Neoplasms, Neoplasm Metastasis, Metastatic Gastrointestinal Carcinoid Tumor

In brief

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.

Key facts

Study ID

NCT05176665

Run by

Shanghai EpimAb Biotherapeutics Co., Ltd.

People needed

152

Starts

2021-10-21

Expected to finish

2025-12-31

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Molecular Pre-screening Exclusion Criteria
• Subject who meets any of the following criteria can't be proceeded to clinical screening:
• 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.
• Screening Exclusion Criteria
• Life expectancy < 3 months.
• Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNS metastases are eligible.
• Pregnant or nursing females.
• Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.
• Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Where it is running

• First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (enrolling)
• Beijing cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Nanfang Hospital — Guangzhou, Guangdong, China (enrolling)
• Hunan Cancer Hospital — Changsha, China (enrolling)
• West China Hospital, Sichuan University — Chengdu, China (enrolling)
• The Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou, China (enrolling)
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, China (enrolling)
• Shandong Cancer Hospital — Jinan, China (enrolling)
• Gansu Provincial Hospital — Lanzhou, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• The Affiliated hospital of Qingdao University — Qingdao, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.