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NCT07218926PHASE3Recruiting

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

GlaxoSmithKline

Start Date

12/3/2025

Completion Date

11/29/2030

Summary

The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

IDRX-42

DRUG

Sunitinib

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Conditions

Gastrointestinal Neoplasms

Locations

GSK Investigational Site

Phoenix, Arizona 85054

United States

GSK Investigational Site

La Jolla, California 92093

United States

GSK Investigational Site

Los Angeles, California 90048

United States

GSK Investigational Site

San Francisco, California 94158

United States

GSK Investigational Site

New Haven, Connecticut 06520

United States

GSK Investigational Site

Jacksonville, Florida 41076

United States

GSK Investigational Site

Miami, Florida 33136

United States

GSK Investigational Site

Orlando, Florida 32806

United States

GSK Investigational Site

Tampa, Florida 33612

United States

GSK Investigational Site

Iowa City, Iowa 52242

United States

GSK Investigational Site

Overland Park, Kansas 66210

United States

GSK Investigational Site

Boston, Massachusetts 02114-2696

United States

GSK Investigational Site

Boston, Massachusetts 02215

United States

GSK Investigational Site

Ann Arbor, Michigan 48109

United States

GSK Investigational Site

Rochester, Minnesota 55905

United States

GSK Investigational Site

St Louis, Missouri 63108

United States

GSK Investigational Site

Omaha, Nebraska 68130

United States

GSK Investigational Site

Lake Success, New York 11042

United States

GSK Investigational Site

New York, New York 10032

United States

GSK Investigational Site

New York, New York 10065

United States

GSK Investigational Site

Rochester, New York 14642

United States

GSK Investigational Site

Durham, North Carolina 27710

United States

GSK Investigational Site

Columbus, Ohio 43210

United States

GSK Investigational Site

Portland, Oregon 97239

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19106

United States

GSK Investigational Site

Philadelphia, Pennsylvania 19111

United States

GSK Investigational Site

Pittsburgh, Pennsylvania 15232

United States

GSK Investigational Site

Spartanburg, South Carolina 29307

United States

GSK Investigational Site

Knoxville, Tennessee 37920

United States

GSK Investigational Site

Dallas, Texas 75246

United States

GSK Investigational Site

Houston, Texas 77030

United States

GSK Investigational Site

Santa Monica, Texas 90404

United States

GSK Investigational Site

Salt Lake City, Utah 84106

United States

GSK Investigational Site

Charlottesville, Virginia 22903

United States

GSK Investigational Site

Seattle, Washington 98109

United States

GSK Investigational Site

Tacoma, Washington 98405

United States

GSK Investigational Site

Garran, Australian Capital Territory 2605

Australia

GSK Investigational Site

Westmead, New South Wales 2145

Australia

GSK Investigational Site

Melbourne, Victoria 3004

Australia

GSK Investigational Site

Leuven, 3000

Belgium

GSK Investigational Site

Barretos, São Paulo 14784-400

Brazil

GSK Investigational Site

São Caetano do Sul, São Paulo 09541-270

Brazil

GSK Investigational Site

Porto Alegre, 90020-090

Brazil

GSK Investigational Site

Recife, 50040000

Brazil

GSK Investigational Site

Vitória, 29043-260

Brazil

GSK Investigational Site

Calgary, Alberta T2N 5G2

Canada

GSK Investigational Site

Toronto, Ontario M5G 2M9

Canada

GSK Investigational Site

Montreal, Quebec H4A 3J1

Canada

GSK Investigational Site

Shanghai, Shanghai Municipality 201315

China

GSK Investigational Site

Beijing, 100036

China

GSK Investigational Site

Hangzhou, 310016

China

GSK Investigational Site

Jinan, 250021

China

GSK Investigational Site

Shanghai, 200127

China

GSK Investigational Site

Wuhan, 430022

China

GSK Investigational Site

Angers, 49055

France

GSK Investigational Site

Bordeaux, 33076

France

GSK Investigational Site

Lille, 59000

France

GSK Investigational Site

Lyon, 69373

France

GSK Investigational Site

Marseille, 13005

France

GSK Investigational Site

Saint-Herblain, 44805

France

GSK Investigational Site

Toulouse, 31059

France

GSK Investigational Site

Villejuif, 94805

France

GSK Investigational Site

Berlin,

Germany

GSK Investigational Site

Essen, 45122

Germany

GSK Investigational Site

Mannheim, 68167

Germany

GSK Investigational Site

Pécs, 7624

Hungary

GSK Investigational Site

Meldola, FC 47014

Italy

GSK Investigational Site

Rozzano MI, Lombardy 20089

Italy

GSK Investigational Site

Bari,

Italy

GSK Investigational Site

Candiolo, 10060

Italy

GSK Investigational Site

Genova, 16132

Italy

GSK Investigational Site

Milan, 20133

Italy

GSK Investigational Site

Milan, 20141

Italy

GSK Investigational Site

Palermo,

Italy

GSK Investigational Site

Roma, 00128

Italy

GSK Investigational Site

Chiba, 277-8577

Japan

GSK Investigational Site

Ehime, 791-0280

Japan

GSK Investigational Site

Fukuoka, 812-8582

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Kanagawa, 247-8533

Japan

GSK Investigational Site

Kumamoto, 860-8556

Japan

GSK Investigational Site

Miyagi, 980-8574

Japan

GSK Investigational Site

Osaka, 565-0871

Japan

GSK Investigational Site

Tokyo, 104-0045

Japan

GSK Investigational Site

Tokyo, 135-8550

Japan

GSK Investigational Site

Nijmegen, 6525 GA

Netherlands

GSK Investigational Site

Oslo, 0379

Norway

GSK Investigational Site

Kielce, 25-640

Poland

GSK Investigational Site

Poznan, 60-569

Poland

GSK Investigational Site

Warsaw, 02-781

Poland

GSK Investigational Site

Bucharest, 013823

Romania

GSK Investigational Site

Bucharest, 022328

Romania

GSK Investigational Site

Craiova, 200542

Romania

GSK Investigational Site

Timișoara, 300166

Romania

GSK Investigational Site

Daegu, 41404

South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, 463 707

South Korea

GSK Investigational Site

Seoul, 03080

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 120-752

South Korea

GSK Investigational Site

Seoul, 138-736

South Korea

GSK Investigational Site

Suwon Kyunggi-do, 16499

South Korea

GSK Investigational Site

Yangsan, 626-770

South Korea

GSK Investigational Site

Barcelona, 08025

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Oviedo, 33006

Spain

GSK Investigational Site

Seville, 41013

Spain

GSK Investigational Site

Valencia, 46009

Spain

GSK Investigational Site

Zaragoza, 50009

Spain

GSK Investigational Site

Changhua, 500

Taiwan

GSK Investigational Site

Kaohsiung City, 807

Taiwan

GSK Investigational Site

Kaohsiung City, 833

Taiwan

GSK Investigational Site

Taipei, 100

Taiwan

GSK Investigational Site

Taipei, 112

Taiwan

GSK Investigational Site

Taoyuan, 333

Taiwan

GSK Investigational Site

Cambridge, CB2 0QQ

United Kingdom

GSK Investigational Site

Edinburgh, EH4 2XR

United Kingdom

GSK Investigational Site

Leeds, LS9 8FF

United Kingdom

GSK Investigational Site

London, NW12BU

United Kingdom

GSK Investigational Site

London, SW3 6JJ

United Kingdom

GSK Investigational Site

Manchester, M20 4BX

United Kingdom

GSK Investigational Site

Sheffield, S10 2SE

United Kingdom