Advanced Solid TumorsPhase 1NCT05685472
MEDI5752 in Japanese Patients With Advanced Solid Tumors.
A Phase 1 study testing MEDI5752 in people with Advanced Solid Tumors, run by AstraZeneca at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MEDI5752
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesJapan
- Study dates
- 8 Dec 2022to 29 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
- 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.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
- Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- MEDI5752
- Keywords
- Advanced Solid Tumors, Phase1, Safety, Tolerability, Pharmacokinetics, Immunogenicity, Antitumor Activity, MEDI5752
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI5752Biological
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| MEDI5752 monotherapy | Experimental | Not described Receives: Biological: MEDI5752 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The endpoints for assessment of antitumor activity is defined by using ORR, PFS, BOR,DCR, DoR and TTR according to RECIST v1.1.
Measured: 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
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]）
Measured: 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
The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: 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
The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.
Measured: To be assessed at at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start8 Dec 2022
- Primary completion8 Aug 2023
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685472
- Sponsor's protocol ID
- D7980C00006
- Status last verified
- Aug 2025
- First submitted
- 9 Nov 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05685472
- Acronym / sponsor ID
- D7980C00006
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, Phase1, Safety, Tolerability, Pharmacokinetics, Immunogenicity, Antitumor Activity, MEDI5752
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDI5752 monotherapy | Experimental | Biological: MEDI5752 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI5752Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. | Biological | MEDI5752 monotherapy |
Primary outcome
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 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 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 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 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.
4 secondary outcomes
Preliminary anti-tumor activitiy of MEDI5752 using Objective Response based on RECIST v1.1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: To be assessed at at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI5752 in people with Advanced Solid Tumors, run by AstraZeneca at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.