Actively Recruiting
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
Led by IDRX, Inc., a wholly owned subsidiary of GSK, LLC · Updated on 2026-05-04
278
Participants Needed
31
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first clinical trial of IDRX-42. The study is designed to evaluate the safety, tolerability, PK, and preliminary antitumor activity of IDRX-42 in adult participants with advanced (metastatic and/or surgically unresectable) GIST.
CONDITIONS
Official Title
First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically or cytologically confirmed metastatic and/or surgically unresectable GIST
- Documented progression on imatinib treatment (Phase 1)
- Documented pathogenic mutation in KIT or any PDGFRA mutation except exon 18 mutations
- At least one measurable lesion by mRECIST v1.1
- ECOG performance status of 0 or 1
- Prior treatment toxicities resolved to Grade 1 or baseline by NCI CTCAE v5.0
- Willing and able to comply with study visits, drug plans, lab tests, and procedures
- For Phase 1b Cohort 1: progressed on imatinib only and refused or ineligible for other standard therapies
- For Phase 1b Cohort 2: progressed on imatinib and sunitinib or additional agents as specified
- For Phase 1b Cohort 3 (US, UK, China, Japan only): treatment naive and refused or ineligible for other standard therapies
- For Phase 1b Cohort 4: same as Cohort 2 plus prior treatment with investigational agents NB003 or THE-630 or bezuclastinib plus sunitinib combination
You will not qualify if you...
- Prior exposure to investigational agents NB003, THE-630, or bezuclastinib plus sunitinib combination except for Cohort 4 participants
- GIST without documented mutation in KIT and PDGFRA genes
- Primary brain cancer or untreated/active central nervous system metastases
- Active uncontrolled infection requiring intravenous antibiotics
- Significant, uncontrolled, or active cardiovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
GSK Investigational Site
Miami, Florida, United States, 33136
Actively Recruiting
2
GSK Investigational Site
Chicago, Illinois, United States, 60611
Actively Recruiting
3
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
GSK Investigational Site
St Louis, Missouri, United States, 63129
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5
GSK Investigational Site
New York, New York, United States, 10065
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6
GSK Investigational Site
Portland, Oregon, United States, 97239
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7
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
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8
GSK Investigational Site
Houston, Texas, United States, 77030
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9
GSK Investigational Site
Leuven, Belgium, 3000
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10
GSK Investigational Site
Beijing, China, 100142
Actively Recruiting
11
GSK Investigational Site
Guangzhou, China
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12
GSK Investigational Site
Wuhan, China, 430022
Actively Recruiting
13
GSK Investigational Site
Bordeaux, France, 33076
Actively Recruiting
14
GSK Investigational Site
Lyon, France
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15
GSK Investigational Site
Marseille, France, 13005
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16
GSK Investigational Site
Villejuif, France, 94805
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17
GSK Investigational Site
Berlin, Germany
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18
GSK Investigational Site
Essen, Germany, 45122
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19
GSK Investigational Site
Milan, Italy, 20133
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20
GSK Investigational Site
Chiba, Japan, 277-8577
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21
GSK Investigational Site
Tokyo, Japan, 104-0045
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22
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
23
GSK Investigational Site
Rotterdam, Netherlands, 3075 EA
Actively Recruiting
24
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 463-707
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25
GSK Investigational Site
Seoul, South Korea, 120-752
Actively Recruiting
26
GSK Investigational Site
Seoul, South Korea, 3080
Actively Recruiting
27
GSK Investigational Site
Seoul, South Korea, 5505
Actively Recruiting
28
GSK Investigational Site
Seoul, South Korea, 6351
Actively Recruiting
29
GSK Investigational Site
Barcelona, Spain
Actively Recruiting
30
GSK Investigational Site
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
31
GSK Investigational Site
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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