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New hope for Tough-to-Treat gut cancer: experimental drug takes on standard therapy

NCT ID NCT07218926

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests a new drug, IDRX-42, against the current standard drug sunitinib in adults with advanced gastrointestinal stromal tumors (GIST) that have spread or can't be removed by surgery and have already been treated with imatinib. About 450 participants will be randomly assigned to receive either IDRX-42 or sunitinib to see which better delays cancer growth and improves survival. The study is open-label, meaning both doctors and patients know which treatment is given.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease. * Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay. * Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy. Exclusion Criteria: * GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation. * Known untreated or active central nervous system metastases. * Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded. * Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.

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Conditions

The condition(s) this trial relates to.

digestive system neoplasm gastrointestinal stromal tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    153 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

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    Phoenix, Arizona, 85054, United States

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    Duarte, California, 91010, United States

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    La Jolla, California, 92093, United States

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    Los Angeles, California, 90048, United States

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    San Francisco, California, 94158, United States

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    Upland, California, 91786, United States

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    Aurora, Colorado, 80045-2517, United States

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    New Haven, Connecticut, 06520, United States

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    Washington D.C., District of Columbia, 20016, United States

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    Jacksonville, Florida, 41076, United States

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    Miami, Florida, 33136, United States

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    Orlando, Florida, 32806, United States

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    Tampa, Florida, 33612, United States

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    Chicago, Illinois, 60611, United States

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    Chicago, Illinois, 60637, United States

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    Iowa City, Iowa, 52242, United States

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    Overland Park, Kansas, 66210, United States

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    Baton Rouge, Louisiana, 70808, United States

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    Baltimore, Maryland, 21287, United States

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    Boston, Massachusetts, 02114-2696, United States

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    Boston, Massachusetts, 02215, United States

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    Ann Arbor, Michigan, 48109, United States

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    Rochester, Minnesota, 55905, United States

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    St Louis, Missouri, 63108, United States

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    Omaha, Nebraska, 68130-2042, United States

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    New Hyde Park, New York, 11042-1118, United States

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    New York, New York, 10032-3747, United States

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    New York, New York, 10065-6007, United States

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    Rochester, New York, 14642, United States

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    Charlotte, North Carolina, 28204, United States

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    Durham, North Carolina, 27710, United States

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    Canton, Ohio, 44718, United States

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    Columbus, Ohio, 43210, United States

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    Portland, Oregon, 97239-3011, United States

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    Philadelphia, Pennsylvania, 19106, United States

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    Philadelphia, Pennsylvania, 19111, United States

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    Pittsburgh, Pennsylvania, 15232, United States

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    Spartanburg, South Carolina, 29307, United States

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    Knoxville, Tennessee, 37920, United States

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    Dallas, Texas, 75246, United States

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    Houston, Texas, 77030, United States

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    Santa Monica, Texas, 90404, United States

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    Salt Lake City, Utah, 84106, United States

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    Charlottesville, Virginia, 22908-0817, United States

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    Fairfax, Virginia, 22031, United States

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    Seattle, Washington, 98109, United States

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    Tacoma, Washington, 98405, United States

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    Milwaukee, Wisconsin, 53226, United States

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    Garran, Australian Capital Territory, 2605, Australia

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    Camperdown, New South Wales, 2050, Australia

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    Westmead, New South Wales, 2145, Australia

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    Melbourne, Victoria, 3004, Australia

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    Leuven, 3000, Belgium

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    Barretos, São Paulo, 14784-400, Brazil

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    São Caetano do Sul, São Paulo, 09541-270, Brazil

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    Porto Alegre, 90020-090, Brazil

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    Recife, 50040000, Brazil

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    Vitória, 29043-260, Brazil

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    Calgary, Alberta, T2N 5G2, Canada

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    Toronto, Ontario, M5G 2M9, Canada

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    Montreal, Quebec, H4A 3J1, Canada

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    Shijiazhuang, Hebei, 050011, China

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    Shanghai, Shanghai Municipality, 201315, China

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    Beijing, 100036, China

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    Chengdu, China

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    Chongqing, 400042, China

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    Guangzhou, 510060, China

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    Guangzhou, 510080, China

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    Guangzhou, 510655, China

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    Hangzhou, 310003, China

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    Hangzhou, 310016, China

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    Jinan, 250021, China

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    Shanghai, 200127, China

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    Wuhan, 430022, China

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    Angers, Maine-Et-Loire, 49100, France

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    Bordeaux, 33076, France

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    Lille, 59000, France

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    Lyon, 69373, France

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    Marseille, 13005, France

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    Saint-Herblain, 44805, France

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    Toulouse, 31059, France

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    Villejuif, 94805, France

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    Cologne, North Rhine-Westphalia, 50937, Germany

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    Essen, North Rhine-Westphalia, 45122, Germany

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    Dresden, Saxony, 01307, Germany

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    Berlin, 13125, Germany

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    Mannheim, 68167, Germany

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    München, 81377, Germany

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    Tübingen, 72076, Germany

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    Pécs, 7624, Hungary

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    Meldola, FC, 47014, Italy

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    Rozzano MI, Lombardy, 20089, Italy

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    Bari, Italy

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    Bologna, 40138, Italy

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    Candiolo, 10060, Italy

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    Genova, 16132, Italy

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    Milan, 20133, Italy

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    Milan, 20141, Italy

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    Padova, 35128, Italy

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    Palermo, Italy

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    Roma, 00128, Italy

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    Chiba, 277-8577, Japan

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    Ehime, 791-0280, Japan

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    Fukuoka, 812-8582, Japan

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    Hokkaido, 060-8648, Japan

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    Kanagawa, 247-8533, Japan

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    Kumamoto, 860-8556, Japan

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    Miyagi, 980-8574, Japan

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    Osaka, 565-0871, Japan

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    Tokyo, 104-0045, Japan

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    Tokyo, 135-8550, Japan

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    Amsterdam, 1066 CX, Netherlands

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    Leiden, 2333 ZA, Netherlands

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    Nijmegen, 6525 GA, Netherlands

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    Rotterdam, 3015 CN, Netherlands

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    Oslo, 0379, Norway

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    Kielce, 25-640, Poland

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    Poznan, 60-569, Poland

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    Warsaw, 02-781, Poland

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    Bucharest, 013823, Romania

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    Bucharest, 022328, Romania

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    Craiova, 200542, Romania

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    Timișoara, 300166, Romania

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    Seoul, Seoul Teugbyeolsi, 06351, South Korea

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    Daegu, 41404, South Korea

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    Seongnam-si Gyeonggi-do, 13620, South Korea

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    Seoul, 03080, South Korea

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    Seoul, 120-752, South Korea

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    Seoul, 138-736, South Korea

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    Suwon Kyunggi-do, 16499, South Korea

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    Yangsan, 626-770, South Korea

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    Barcelona, 08025, Spain

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    Barcelona, 08035, Spain

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    Madrid, 28007, Spain

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    Madrid, 28040, Spain

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    Madrid, 28040, Spain

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    Oviedo, 33006, Spain

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    Seville, 41013, Spain

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    Valencia, 46009, Spain

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    Zaragoza, 50009, Spain

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    Changhua, 500, Taiwan

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    Kaohsiung City, 807, Taiwan

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    Kaohsiung City, 833, Taiwan

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    Taipei, 100, Taiwan

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    Taipei, 112, Taiwan

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    Taoyuan, 333, Taiwan

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    Manchester, Greater Manchester, M20 4BX, United Kingdom

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    Edinburgh, Midlothian, EH4 2XR, United Kingdom

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    Cambridge, CB2 0QQ, United Kingdom

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    Leeds, LS9 8FF, United Kingdom

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    London, NW12BU, United Kingdom

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    London, SW3 6JJ, United Kingdom

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    Sheffield, S10 2SE, United Kingdom

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