35 GIST Clinical Trials Recruiting Now (July 2026): Gastrointestinal Stromal Tumor — KIT/PDGFRA, SDH-Deficient, Olverembatinib

Last updated: July 1, 2026

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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. Sunitinib and regorafenib are multikinase TKIs (VEGFR + KIT + PDGFR); GIST is one of the defining indications for the class alongside HCC and RCC. For cross-cancer multikinase TKI comparisons (receptor coverage, sequencing, class side effects), see the Multikinase Inhibitors mechanism hub.

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 - StrateGIST 3: IDRX-42 (GSK6042981) vs sunitinib in metastatic/unresectable GIST after imatinib (Phase 3, GSK)
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) — same drug as StrateGIST 3 Phase 3 above (earlier-line dose-finding)
NCT03594422 - HQP1351 (olverembatinib) in GIST/other solid tumors (Phase 1)

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 34 GIST trials on ClinicalTrials.gov →

Frequently Asked Questions

How do I find GIST clinical trials I'm eligible for?

Paste your medical summary into ClinTrialFinder to get AI-matched GIST trials in minutes. The tool considers your KIT or PDGFRA mutation type, prior TKI treatments, and disease status.

What GIST trials are currently recruiting?

There are 35 recruiting interventional trials for gastrointestinal stromal tumors in July 2026 including 4 Phase 3 studies. Recent Phase 3: PEAK CGT9486 + sunitinib vs sunitinib NCT05208047, IDRX-42 (GSK6042981) vs sunitinib NCT07218926, NB003 advanced GIST NCT07379047. Active classes: next-generation TKIs (olverembatinib for SDH-deficient, IDRX-42), CGT9486 + sunitinib first-line, immunotherapy combinations, and novel targeted agents for KIT/PDGFRA-mutant and SDH-deficient subtypes.

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