A Dose Escalation Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 33
Summary
- Conditions
- Neoplasm Metastasis
- Neoplasms
- Non -Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 advanced solid tumors who have progressed on available standard therapies or for which no standard th...
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 advanced solid tumors who have progressed on available standard therapies or for which no standard therapy exists. The study consists of two parts: Phase I (dose escalation) and Phase II (cohort expansion). The study is planning to recruit tentatively 33-66 subjects with advanced/metastatic solid tumors in phase I and about 40 patients with EGFR mutant Non-Small Cell Lung Cancer (NSCLC) in Phase II. Both parts consist of screening period (-28 to -1 days), treatment cycles (each cycle is 28 days), and follow-up period (30 days safety follow up and disease progression follow up).
Tracking Information
- NCT #
- NCT03797391
- Collaborators
- Covance
- Investigators
- Principal Investigator: Nashat Y. Gabrail, MD Gabrail Cancer Center Research
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