A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Japanese Subjects With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- MEDI5752
- Conditions
- Advanced Solid Tumors
- Sponsor
- AstraZeneca
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- The number of subjects experiencing dose-limiting toxicities (DLTs)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This is a Phase 1, open-label study evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity of MEDI5752 in Japanese patients with advanced solid solid tumors.
Detailed Description
\<Objectives\> Primary Objective: To evaluate the safety and tolerability of MEDI5752 in Japanese subjects with advanced solid tumors. Secondary Objective: To assess the anti-tumor activity and efficacy of MEDI5752. To describe the pharmacokinetics of MEDI5752. Exploratory Objective: To conduct exploratory research into factors that may be predictive of response or may influence the progression of cancer and/or response (efficacy) to MEDI5752. Eligible patients will be administered as a single dose at each Cycle Day1. Each cycle from Cycle 1 has a duration of 21 days. A minimum of 3 and a maximum of 9 evaluable patients will be enrolled in each cohort.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MEDI5752 monotherapy
Intervention: MEDI5752
Outcomes
Primary Outcomes
The number of subjects experiencing dose-limiting toxicities (DLTs)
Time Frame: Up to 21 days following the first dose
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The number of subjects experiencing treatment related adverse events (AEs)
Time Frame: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v5.0.
The number of subjects experiencing treatment related serious adverse events (SAEs)
Time Frame: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
The number of subjects experiencing changes from baseline in vital signs reported as adverse events
Time Frame: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The number of subjects experiencing abnormal laboratory evaluations
Time Frame: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events
Time Frame: From the time of informed consent through 90 days following termination of treatment with investigational product
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
Secondary Outcomes
- PD-L1 Expression in subjects with advanced solid tumors(To be assessed at at baseline)
- Preliminary anti-tumor activitiy of MEDI5752 using Objective Response based on RECIST v1.1(From the first dose of study drug through the date of documented progression, end of study, or date of death until study completion assessed up to 16 months.)
- Pharmacokinetics of MEDI5752(At Cycle1Day1, ,Cycle1Day2, Cycle1Day3, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8, Cycle3Day1, Cycle4Day1, Cycle5Day1, Cycle6Day1, Cycl7Day1, every 6 weeks after Cycle7Day1 (each cycle is 21 days) and up to 90 days following end of treatment.)
- Immunogenicity of MEDI5752(At Cycle1Day1, Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8, Cycle3Day1, Cycle4Day1, Cycle5Day1, Cycle6Day1, Cycl7Day1, every 6 weeks after Cycle7Day1 (each cycle is 21 days) and up to 90 days following end of treatment.)