RECRUITING

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Conditions

Neoplasms Neoplasm Metastasis Metastatic Gastrointestinal Carcinoid Tumor Human Bispecific antibody Epidermal Growth Factor Receptor (EGFR)c-Mesenchymal-Epithelial Transition (cMet)Neoplasms， Neoplasm Metastasis EMB-01，Tyrosine Kinase Inhibitor (TKI) Resistant

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-21

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05176665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). 1. Able to understand and willing to sign the Informed Consent Form (ICF). 2. 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: 1. 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. 2. Have measurable disease as defined by RESIST v 1.1. 3. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit. 4. Must have adequate organ function. 5. Regarding prior anti-tumor therapy: 1. 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. 2. 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. 3. 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. 6. 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. 7. ECOG score ≤1.	1. Patients who are unwilling to sign the molecular pre-screening ICF. 2. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria. 3. 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. 1. Life expectancy \< 3 months. 2. 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. 3. Pregnant or nursing females. 4. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed. 5. 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.

Inclusion Criteria

Exclusion 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).
1. Able to understand and willing to sign the Informed Consent Form (ICF).
2. 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:
1. 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.
2. Have measurable disease as defined by RESIST v 1.1.
3. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.
4. Must have adequate organ function.
5. Regarding prior anti-tumor therapy:
1. 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.
2. 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.
3. 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.
6. 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.
7. ECOG score ≤1.

1. Patients who are unwilling to sign the molecular pre-screening ICF.
2. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
3. 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.
1. Life expectancy \< 3 months.
2. 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.
3. Pregnant or nursing females.
4. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.
5. 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.

Contacts and Locations

Study Contact

Rong Wang, M.Sc

CONTACT

+86-21-61043299

CT.info@epimab.com

Di Hu, M.Sc

CONTACT

+862161043299

CT.info@epimab.com

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-21

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-10-21

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Human Bispecific antibody
Epidermal Growth Factor Receptor (EGFR)
c-Mesenchymal-Epithelial Transition (cMet)
Neoplasms， Neoplasm Metastasis
Neoplasm Metastasis
EMB-01，Tyrosine Kinase Inhibitor (TKI) Resistant

Additional Relevant MeSH Terms

Neoplasms
Neoplasm Metastasis
Metastatic Gastrointestinal Carcinoid Tumor