ClinicalTrials.gg
Active, not recruitingNCT03530397Updated Aug 21, 2026

A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors

A Phase 1 interventional study of MEDI5752 and Pemetrexed in Selected Advanced Solid Tumors, sponsored by MedImmune LLC. Active, not recruiting at 40 sites in 9 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

Read the detailed description

This is a phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability, and efficacy, pharmacokinetics and Immunogenicity of MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

02

Conditions studied

  • Selected Advanced Solid Tumors

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Keywords

  • Advanced solid tumors
  • MEDI5752
  • immuno-oncology
  • Cancer
  • PD-1/CTLA-4 Bispecific
  • PD-1
  • CTLA-4
  • Bispecific
  • Chemotherapy
  • Pemetrexed
  • Carboplatin
  • Pembrolizumab
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 400 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.

First submitted after MedImmune LLC became part of AstraZeneca.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years at the time of screening
  2. World Health Organization/ (ECOG) performance status of 0 or 1 at enrollment
  3. ≥ 12 weeks
  4. or cytologically-confirmed advanced solid tumors
  5. Subjects who have received prior , anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, , biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a as applicable
  6. Females of who are sexually active with a nonsterilized male partner must use at least one highly effective method of
  7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
  8. Subjects must have at least one
  9. Adequate organ and marrow function
  10. Written and any locally required authorization
  11. Subjects must provide tumor material as applicable

Exclusion criteria

Exclusion Criteria

  1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
  2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
  3. For subjects who have received prior , anti-PD-L1, or anti-CTLA-4:

    1. 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 product.
    2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
    3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
  4. Current or prior use of medication within 14 days before the first dose of investigational product is excluded.
  5. Receipt of within 30 days prior to the first dose of investigational product.
  6. Active or prior documented or inflammatory disorders
  7. History of active primary immunodeficiency:
  8. History of organ transplant
  9. Known allergy or reaction to any component of the planned study treatment.
  10. Untreated CNS disease, , or cord compression
  11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
  12. 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
  13. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of who are not willing to employ one highly effective method of
  14. 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 .
  15. 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
  16. 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Arm A: MEDI5752

    MEDI5752

    Biological: MEDI5752

  • Experimental
    Arm B: MEDI5752 and chemotherapy

    MEDI5752, pemetrexed, carboplatin and paclitaxel.

    Biological: MEDI5752 · Drug: Pemetrexed · Drug: Carboplatin · Drug: Paclitaxel or Nab-Paclitaxel

  • Active comparator
    Arm C: Pembrolizumab and chemotherapy

    pembrolizumab, pemetrexed, and carboplatin

    Drug: Pemetrexed · Drug: Carboplatin · Biological: Pembrolizumab

Interventions

  • BiologicalMEDI5752

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

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

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

  • BiologicalPembrolizumab

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

  • DrugPaclitaxel or Nab-Paclitaxel

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

06

What researchers measure

Primary outcomes

  1. The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase)

    The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  2. Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase)

    The primary endpoint of antitumor activity include Objective Response and will be based on all post baseline disease assessments that occur prior to initiation of subsequent anticancer therapy.

    Time frame: From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after the last patient starts treatment, whichever should occur first

  3. The number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase)

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

    Time frame: Up to 21 days following the first dose

  4. The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase)

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

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  5. The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase)

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

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  6. The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase)

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

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  7. The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase)

    The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

Secondary outcomes

  1. Pharmacokinetics of MEDI5752: Cmax

    The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include maximum observed concentration (Cmax)

    Time frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment

  2. Pharmacokinetics of MEDI5752: AUC

    The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include area under the concentration-time curve (AUC)

    Time frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment

  3. Pharmacokinetics of MEDI5752: Clearance

    The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include clearance (CL)

    Time frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment

  4. Pharmacokinetics of MEDI5752: t 1/2

    The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. PK parameters that may be modeled on this data include terminal phase half life (t 1/2)

    Time frame: To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment.

  5. Ability of MEDI5752 to generate immune response in subjects with advanced solid tumors

    The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)

    Time frame: To be assessed at Day 1, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment.

  6. PD-L1 Expression in subjects with advanced solid tumors

    The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.

    Time frame: To be assessed at baseline

  7. Preliminary Antitumor Activity: Duration of Response

    The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the documentation of OR to the first documentation of disease progression or death due to any cause.

    Time frame: From the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first

  8. Preliminary Antitumor Activity: Disease Control

    The endpoints for assessment of antitumor activity include disease control (DC) and is defined as CR, PR, or SD according to RECIST v1.1.

    Time frame: From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first

  9. Preliminary Antitumor Activity: Progression Free Survival

    The endpoints for assessment of antitumor activity include progression free survival (PFS) and is defined as the duration measured from the start of treatment with investigational product to the first documentation of disease progression or death due to any cause.

    Time frame: From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first

  10. Preliminary Antitumor Activity: Overall Survival

    The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the duration measured from the start of treatment with investigational product until death due to any cause.

    Time frame: From the first dose of study drug through the end of study, or date of death, or two years after last subject starts treatment whichever should occur first

  11. The number of subjects experiencing treatment related adverse events (AEs) (Dose-expansion phase)

    The secondary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  12. The number of subjects experiencing abnormal laboratory evaluations (Dose-expansion phase)

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

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  13. The number of subjects experiencing Changes from baseline in vital signs reported as adverse events (Dose-expansion phase)

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

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

  14. The number of subjects experiencing abnormal ECGs reported as adverse events (Dose-expansion phase)

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

    Time frame: From the time of informed consent through 14 days following termination of treatment with investigational product

  15. The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-expansion phase)

    The secondary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03

    Time frame: From the time of informed consent through 114 days following termination of treatment with investigational product

07

Study locations

40 sites
  • Research Site
    Detroit, Michigan 48202, United States
  • Research Site
    New York, New York 10065, United States
  • Research Site
    Chapel Hill, North Carolina 27599, United States
  • Research Site
    Providence, Rhode Island 02903, United States
  • Research Site
    Chattanooga, Tennessee 37404, United States
  • Research Site
    Nashville, Tennessee 37203, United States
  • Research Site
    Fairfax, Virginia 22031, United States
  • Research Site
    Melbourne, 3000, Australia
  • Research Site
    Melbourne, 3004, Australia
  • Research Site
    Randwick, 2031, Australia
  • Research Site
    Bordeaux, 33075, France
  • Research Site
    Lyon, 69373, France
  • Research Site
    Villejuif, 94805, France
  • Research Site
    Meldola, 47014, Italy
  • Research Site
    Naples, 80131, Italy
  • Research Site
    Ravenna, 48121, Italy
  • Research Site
    Roma, 168, Italy
  • Research Site
    Amsterdam, 1066 CX, Netherlands
  • Research Site
    Lisbon, 1649-035, Portugal
  • Research Site
    Porto, 4200-072, Portugal
  • Research Site
    Cheongju-si, 28644, South Korea
  • Research Site
    Gyeonggi-do, 13620, South Korea
  • Research Site
    Incheon, 21565, South Korea
  • Research Site
    Seoul, 03080, South Korea
  • Research Site
    Seoul, 03722, South Korea
  • Research Site
    Seoul, 05505, South Korea
  • Research Site
    Seoul, 06351, South Korea
  • Research Site
    A Coruña, 15006, Spain
  • Research Site
    Barcelona, 08003, Spain
  • Research Site
    Barcelona, 08028, Spain
  • Research Site
    Barcelona, 08035, Spain
  • Research Site
    Barcelona, 08041, Spain
  • Research Site
    Barcelona, 08916, Spain
  • Research Site
    Majadahonda, 28222, Spain
  • Research Site
    Málaga, 29010, Spain
  • Research Site
    Pamplona, 31008, Spain
  • Research Site
    Valencia, 46010, Spain
  • Research Site
    Taichung, 40705, Taiwan
  • Research Site
    Tainan, 70403, Taiwan
  • Research Site
    Taipei, 10048, Taiwan
08

References and documents

Individual participant data

Plan to share: 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.

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 de-identified 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.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jul 2025, 86 months.

Of 677 industry-sponsored phase 1 interventional studies under Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's 86 months is above that.

Counting every sponsor, half of 903 studies reached it within 40 months; a quarter within 23 and three quarters within 64.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2018
First posted
May 21, 2018
StartActual
Apr 24, 2018
Primary completionActual
Jul 14, 2025
CompletionEst.
Nov 30, 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03530397
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
May 21, 2018
Start date
Apr 24, 2018
Primary completion
Jul 14, 2025
Completion
Nov 30, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Deepa Subramaniam, MD, MSc
principal investigator · AstraZeneca

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Volrustomig

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