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New treatment option for Neoplasms
Official title EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
ClinicalTrials.gov ID: NCT05176665
What this study is testing
What is EMB-01?
EMB-01 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for neoplasms.
Also referred to as FIT-013a.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Molecular Pre-screening 1. 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...
- Histologically/cytologically confirmed advanced/metastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). To...
You likely can't join 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...
- Life expectancy \< 3 months.
- Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with...
See the full eligibility criteria
- Molecular Pre-screening 1. 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...
- 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...
- 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)...
- 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...
- ECOG score ≤1.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Changsha, China
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Harbin, China
- Jinan, China
- Lanzhou, China
- Qingdao, China
- Shanghai, China
- Xi'an, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Changsha, China; Chengdu, China; Guangzhou, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.