MEDI5752 in Japanese Patients With Advanced Solid Tumors.

NCT05685472 | Completed Phase 1

• 1 other identifier: D7980C00006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; Phase1; Safety; Tolerability; Pharmacokinetics; Immunogenicity; Antitumor Activity; MEDI5752

Outcome Measures

Primary Outcomes (6)

• The number of subjects experiencing treatment related adverse events (AEs)

  The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v5.0.

  From the time of informed consent through 90 days following termination of treatment with investigational product

• The number of subjects experiencing treatment related serious adverse events (SAEs)

  The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.

  From the time of informed consent through 90 days following termination of treatment with investigational product

• The number of subjects experiencing dose-limiting toxicities (DLTs)

  The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.

  Up to 21 days following the first dose

• The number of subjects experiencing abnormal laboratory evaluations

  The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.

  From the time of informed consent through 90 days following termination of treatment with investigational product

• The number of subjects experiencing changes from baseline in vital signs reported as adverse events

  The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.

  From the time of informed consent through 90 days following termination of treatment with investigational product

• The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events

  The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.

  From the time of informed consent through 90 days following termination of treatment with investigational product

Secondary Outcomes (4)

• 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.

• PD-L1 Expression in subjects with advanced solid tumors

  To be assessed at at baseline

Study Arms (1)

MEDI5752 monotherapy

EXPERIMENTAL

Biological: MEDI5752

Interventions

MEDI5752 BIOLOGICAL

Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.

MEDI5752 monotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of screening
• World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• Life expectancy ≥ 12 weeks
• Histologically or cytologically-confirmed advanced solid tumors
• Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
• Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom from Day 1 and for 90 days after the final dose of investigational product.
• Subjects must have at least one measurable lesion
• Adequate organ and marrow function
• Signed and dated written informed consent
• Subjects must provide tumor material as applicable

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)
• Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
• For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
• Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
• Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
• All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
• Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
• Active or prior documented autoimmune or inflammatory disorders
• History of organ transplant
• Known allergy or reaction to any component of the planned study treatment.
• Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
• Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
• Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
• Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Chūōku, 104-0045, Japan

Location

Research Site

Kashiwa, 227-8577, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: January 17, 2023
• Study Start: December 8, 2022
• Primary Completion: August 8, 2023
• Study Completion: July 29, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

JP (2)