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

NCT07218926 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 3003832025-522229-37-00
• Study Type: interventional
• Target: 450
• Locations: 19 countries
• Sites: 124

Brief 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.

Conditions

Gastrointestinal Neoplasms

Keywords

GSK6042981; IDRX-42; Sunitinib; Imatinib; Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.

  Up to approximately 130 weeks

Secondary Outcomes (13)

• Overall Survival (OS)

  Up to approximately 261 weeks

• Progression-Free Survival (PFS)

  Up to approximately 261 weeks

• Confirmed Overall Objective Response Rate (ORR)

  Up to approximately 261 weeks

• Time to Response (TTR)

  Up to approximately 261 weeks

• Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)

  Up to approximately 261 weeks

Study Arms (2)

IDRX-42 (GSK6042981)

EXPERIMENTAL

Drug: IDRX-42

Sunitinib

ACTIVE COMPARATOR

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib will be administered.

Sunitinib

IDRX-42 DRUG

IDRX-42 will be administered.

Also known as: velzatinib - subject to USAN approval

IDRX-42 (GSK6042981)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (124)

GSK Investigational Site

Phoenix, Arizona, 85054, United States

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GSK Investigational Site

La Jolla, California, 92093, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

San Francisco, California, 94158, United States

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GSK Investigational Site

New Haven, Connecticut, 06520, United States

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GSK Investigational Site

Jacksonville, Florida, 41076, United States

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GSK Investigational Site

Miami, Florida, 33136, United States

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GSK Investigational Site

Orlando, Florida, 32806, United States

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GSK Investigational Site

Tampa, Florida, 33612, United States

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GSK Investigational Site

Iowa City, Iowa, 52242, United States

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GSK Investigational Site

Overland Park, Kansas, 66210, United States

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GSK Investigational Site

Boston, Massachusetts, 02114-2696, United States

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GSK Investigational Site

Boston, Massachusetts, 02215, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

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GSK Investigational Site

Rochester, Minnesota, 55905, United States

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GSK Investigational Site

St Louis, Missouri, 63108, United States

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GSK Investigational Site

Omaha, Nebraska, 68130, United States

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GSK Investigational Site

Lake Success, New York, 11042, United States

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GSK Investigational Site

New York, New York, 10032, United States

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GSK Investigational Site

New York, New York, 10065, United States

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GSK Investigational Site

Rochester, New York, 14642, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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GSK Investigational Site

Columbus, Ohio, 43210, United States

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GSK Investigational Site

Portland, Oregon, 97239, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19106, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19111, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

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GSK Investigational Site

Spartanburg, South Carolina, 29307, United States

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GSK Investigational Site

Knoxville, Tennessee, 37920, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Santa Monica, Texas, 90404, United States

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Salt Lake City, Utah, 84106, United States

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Charlottesville, Virginia, 22903, United States

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Seattle, Washington, 98109, United States

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Tacoma, Washington, 98405, United States

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GSK Investigational Site

Garran, Australian Capital Territory, 2605, Australia

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GSK Investigational Site

Westmead, New South Wales, 2145, Australia

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GSK Investigational Site

Melbourne, Victoria, 3004, Australia

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Barretos, São Paulo, 14784-400, Brazil

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GSK Investigational Site

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

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GSK Investigational Site

Porto Alegre, 90020-090, Brazil

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GSK Investigational Site

Recife, 50040000, Brazil

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GSK Investigational Site

Vitória, 29043-260, Brazil

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GSK Investigational Site

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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Shanghai, Shanghai Municipality, 201315, China

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GSK Investigational Site

Beijing, 100036, China

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GSK Investigational Site

Hangzhou, 310016, China

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GSK Investigational Site

Jinan, 250021, China

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GSK Investigational Site

Shanghai, 200127, China

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GSK Investigational Site

Wuhan, 430022, China

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GSK Investigational Site

Angers, 49055, France

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GSK Investigational Site

Bordeaux, 33076, France

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GSK Investigational Site

Lille, 59000, France

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GSK Investigational Site

Lyon, 69373, France

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GSK Investigational Site

Marseille, 13005, France

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GSK Investigational Site

Saint-Herblain, 44805, France

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GSK Investigational Site

Toulouse, 31059, France

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GSK Investigational Site

Villejuif, 94805, France

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GSK Investigational Site

Berlin, Germany

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GSK Investigational Site

Essen, 45122, Germany

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GSK Investigational Site

Mannheim, 68167, Germany

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GSK Investigational Site

Pécs, 7624, Hungary

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GSK Investigational Site

Meldola, FC, 47014, Italy

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GSK Investigational Site

Rozzano MI, Lombardy, 20089, Italy

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Bari, Italy

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GSK Investigational Site

Candiolo, 10060, Italy

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GSK Investigational Site

Genova, 16132, Italy

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GSK Investigational Site

Milan, 20133, Italy

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GSK Investigational Site

Milan, 20141, Italy

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Palermo, Italy

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GSK Investigational Site

Roma, 00128, Italy

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GSK Investigational Site

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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GSK Investigational Site

Kumamoto, 860-8556, Japan

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Miyagi, 980-8574, Japan

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GSK Investigational Site

Osaka, 565-0871, Japan

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Tokyo, 104-0045, Japan

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Tokyo, 135-8550, Japan

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Nijmegen, 6525 GA, 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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GSK Investigational Site

Bucharest, 013823, Romania

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GSK Investigational Site

Bucharest, 022328, Romania

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GSK Investigational Site

Craiova, 200542, Romania

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GSK Investigational Site

Timișoara, 300166, Romania

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GSK Investigational Site

Daegu, 41404, South Korea

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GSK Investigational Site

Seongnam-si Gyeonggi-do, 463 707, South Korea

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GSK Investigational Site

Seoul, 03080, South Korea

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GSK Investigational Site

Seoul, 06351, South Korea

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GSK Investigational Site

Seoul, 120-752, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

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GSK Investigational Site

Suwon Kyunggi-do, 16499, South Korea

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GSK Investigational Site

Yangsan, 626-770, South Korea

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GSK Investigational Site

Barcelona, 08025, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Oviedo, 33006, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Valencia, 46009, Spain

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GSK Investigational Site

Zaragoza, 50009, Spain

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GSK Investigational Site

Changhua, 500, Taiwan

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GSK Investigational Site

Kaohsiung City, 807, Taiwan

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GSK Investigational Site

Kaohsiung City, 833, Taiwan

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GSK Investigational Site

Taipei, 100, Taiwan

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GSK Investigational Site

Taipei, 112, Taiwan

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GSK Investigational Site

Taoyuan, 333, Taiwan

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GSK Investigational Site

Cambridge, CB2 0QQ, United Kingdom

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GSK Investigational Site

Edinburgh, EH4 2XR, United Kingdom

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GSK Investigational Site

Leeds, LS9 8FF, United Kingdom

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GSK Investigational Site

London, NW12BU, United Kingdom

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GSK Investigational Site

London, SW3 6JJ, United Kingdom

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GSK Investigational Site

Manchester, M20 4BX, United Kingdom

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GSK Investigational Site

Sheffield, S10 2SE, United Kingdom

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MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors

Interventions

IDRX-42; Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): November 29, 2030
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); JP (10); US (36); PL (3); FR (8); NL (1); BR (5); RO (4); IT (9); ES (9); BE (1); CN (6); NO (1); TW (6); AU (3); DE (3); HU (1); GB (7); KR (8)