GIST Clinical Trials (2026): 28 Recruiting Interventional Studies

Last updated: March 10, 2026

Current Clinical Trial Landscape

About gastrointestinal stromal tumor (GIST):

GIST is the most common mesenchymal tumor of the GI tract. ~85% have KIT or PDGFRA mutations. Highly responsive to tyrosine kinase inhibitors (TKIs). SDH-deficient GIST is a distinct subtype requiring different approaches.

Active research areas in 2026:

TKI optimization: adjuvant duration, ctDNA-guided therapy
Novel TKIs: IDRX-42, DCC-3009, olverembatinib
SDH-deficient GIST-specific therapies
Antibody-drug conjugates (c-Kit ADC)

Standard of care: Localized: surgery ± adjuvant imatinib (3 years for high-risk). Metastatic: imatinib 1st line → sunitinib 2nd line → regorafenib 3rd line → ripretinib 4th line.

Recruiting Trials by Treatment Setting

Adjuvant Therapy

After surgery for resectable GIST:

NCT05385549 - 5 years adjuvant imatinib (extended duration)
NCT05009927 - Imatinib after 10 years of treatment

First-Line Metastatic

For newly diagnosed metastatic/unresectable GIST:

NCT05493215 - Imatinib therapeutic drug monitoring (TDM)

Second-Line and Beyond

After progression on imatinib:

NCT07218926 - IDRX-42 vs sunitinib (Phase 3)
NCT05366816 - ctDNA-guided sunitinib and regorafenib
NCT05905887 - Rivoceranib plus paclitaxel

Trials by Treatment Approach

Novel TKIs

Next-generation tyrosine kinase inhibitors targeting resistant mutations:

NCT05489237 - IDRX-42 first-in-human (Phase 1)
NCT06629234 - DCC-3009 master protocol
NCT03594422 - HQP1351 (olverembatinib)
NCT06654246 - Ziftomenib + imatinib combination

SDH-Deficient GIST

Trials specifically for SDH-deficient/wild-type GIST (no KIT/PDGFRA mutations):

NCT06640361 - Olverembatinib in SDH-deficient GIST (Phase 3)
NCT05661643 - Temozolomide in SDH-deficient GIST

Antibody-Drug Conjugates

NCT06805825 - NN3201 (c-Kit specific ADC)

Combination Therapies

NCT05957367 - Inlexisertib (DCC-3116) combinations
NCT06380816 - UCB4594 in advanced cancers

View all 28 GIST trials on ClinicalTrials.gov →

Trial listings from ClinicalTrials.gov. Page summaries generated by AI and may contain errors. Always verify with your healthcare provider.

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