MEDI5752 in Japanese Patients With Advanced Solid Tumors.
- Registration Number
- NCT05685472
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MEDI5752 monotherapy MEDI5752 -
- Primary Outcome Measures
Name Time Method The number of subjects experiencing dose-limiting toxicities (DLTs) 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) 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) 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 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 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 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 Outcome Measures
Name Time Method PD-L1 Expression in subjects with advanced solid tumors To be assessed at at baseline The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.
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. The endpoints for assessment of antitumor activity is defined by using ORR, PFS, BOR,DCR, DoR and TTR according to RECIST v1.1.
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. The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. (e.g., Maximum plasma concentration\[Cmax\]）
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. The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)
Trial Locations
- Locations (1)
Research Site
🇯🇵Kashiwa, Japan