Last updated: May 30, 2023
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Neoplasm Metastasis
Neoplasms
Treatment
EMB-01
Clinical Study ID
NCT03797391
EMB01X101
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Molecular Pre-screening Inclusion criteria (Phase II only)
- The patient must sign the molecular pre-screening Inform Consent to allow for themolecular pre-screening process. All patients must have documented evidence of EGFRand/or cMet aberrations. Screening Inclusion Criteria
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Histologically/cytologically confirmed advanced/metastatic solid tumors withmeasurable disease [Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]: Phase I: advanced/metastatic solid tumors including but not limited to NSCLC,colorectal cancer, gastric cancer and liver cancer refractory to standard therapy orfor which no standard therapy is available or accessible. Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMETaberration, and have progressed after standard treatment (including platinum-basedtherapy) or are intolerant to standard treatment. Additionally, patients with T790Mmutation have received FDA/Health Authority approved therapies (if accessible) forthis indication (i.e., osimertinib) and have progressed or became intolerant. A patient who has refused all currently available therapy is allowed to enroll, butmust be documented in the source record.
- Must have adequate organ function.
- Regarding prior anti-tumor therapy:
- Must have stopped treatment at least 4 weeks or within 5 half-lives.
- Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must havestopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticalsare taken within 8 weeks before first dose of EMB-01.
- Patients must have recovered to ≤Grade 1 from the adverse effects of such abovetreatment before beginning study treatment.
- Female patient with fertility or male patient whose partner has fertility should useone or more contraceptive methods for contraception starting from screening period andcontinue throughout the study treatment and for 3 months.
- ECOG score 0 or 1 for phase I, and ≤2 for phase II.
Exclusion
Exclusion Criteria: Molecular Pre-screening Exclusion Criteria (Phase II only) Subject who meets any of the follow criteria can't be proceeded to clinical screening:
- Patients who are unwilling to sign the molecular pre-screening ICF.
- Patients for whom local EGFR and/or cMET data or the results of central laboratorytesting do not meet the molecular pre-screening inclusion criteria. Screening Exclusion Criteria
- Life expectancy < 3 months.
- Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
- Pregnant or nursing females.
- Subjects who have had major surgery within 28 days prior to screening.
- Serious underlying medical conditions, including but not limited to un-controlledhypertension, other cardiovascular disease or diabetes, ongoing or active infection,psychiatric, psychological, familial or geographical condition that, in the judgmentof the investigator, may interfere the compliance with study treatment.
Study Design
Total Participants: 186
Treatment Group(s): 1
Primary Treatment: EMB-01
Phase: 1/2
Study Start date:
December 13, 2018
Estimated Completion Date:
January 15, 2026
Study Description
Connect with a study center
Guangdong General Hospital
Guangzhou, Guang Dong 510080
ChinaActive - Recruiting
Shanghai Chest Hosptial
Shanghai, Shanghai 200030
ChinaActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Gabrail Cancer Center Research
Canton, Ohio 44718
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.