Status:
RECRUITING
A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors
Lead Sponsor:
Shanghai EpimAb Biotherapeutics Co., Ltd.
Collaborating Sponsors:
Covance
Conditions:
Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors
Detailed Description
This is a first-in-human (FIH), open-label, Phase I/II study of EMB-01, a bispecific Epidermal growth factor receptor (EGFR) and c-Mesenchymal-Epithelial Transition (cMet) antibody, in patients with a...
Eligibility Criteria
Inclusion
- Molecular Pre-screening Inclusion criteria (Phase II only)
- The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/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 with measurable 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 or for which no standard therapy is available or accessible.
- Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMET aberration, and have progressed after standard treatment (including platinum-based therapy) or are intolerant to standard treatment. Additionally, patients with T790M mutation have received FDA/Health Authority approved therapies (if accessible) for this indication (i.e., osimertinib) and have progressed or became intolerant.
- A patient who has refused all currently available therapy is allowed to enroll, but must 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 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 must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment.
- 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 0 or 1 for phase I, and ≤2 for phase II.
Exclusion
- 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 laboratory testing 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-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2026
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03797391
Start Date
December 13 2018
End Date
January 15 2026
Last Update
May 31 2023
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
3
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
4
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080