TRIAL DETAIL

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy (StrateGIST 3)

Drug:
Trial Name:
A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy (StrateGIST 3)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 12/03/2025
Age of Trial (yrs) .4
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT/PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
300383 2025-522229-37-00 ( EU Trial (CTIS) Number )
Sponsor:
GlaxoSmithKline
Patient Contact:
US GSK Clinical Trials CallCenter 877-379-3718 GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Contact email:
Contact Phone:
Randomized:
Randomized
IV or Oral:
Oral
Trial Notes:
Eligibility Criteria:

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.
Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.

Trial Links
 

Trial Results

Drug Information
The Potential of c-KIT Kinase inhibitors in Cancer Treatment
 
MedCity News 8/2/2022: Aiming to bring drug combos into earlier lines of cancer therapy, IDRx lands $122M
 
IDRx Presents Preliminary Clinical Data from Ongoing Phase 1 StrateGIST Study at CTOS 2023 Supporting Best-in-Class Potential of IDRX-42 in Patients with GIST
 
Merck 2/28/2025 M4205 (IDRX-42) is a highly selective and potent inhibitor of relevant oncogenic driver and resistance variants of KIT in cancer
 

Trial Sites

Name
Address
City
State
Zip
Country
1515 Holcombe Blvd.
Houston
TX
77030
USA
1624 South I Street
Tacoma
WA
98405
USA
17201 Wright Street, Suite 200
Omaha
NE
68130
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
1926 Alcoa Hwy
Knoxville
TN
37920
USA
610 University Ave
Toronto
ON
M5G 2M9
Canada
197 Fulham Rd.
London
SW3 6JJ
UK
Manchester
M20 4BX
UK
Chiba
277-8577
Japan
Sapporo
Hokkaido
060-8648
Japan
Osaka
565-0871
Japan
Chuo-ku
Tokyo
104-0045
Japan
Fukuoka City
Japan
Kanagawa
247-8533
Japan
161 Fort Washington Avenue
New York
NY
10032
USA
333 Cottman Ave.
Philadelphia
PA
19111
USA
Matsuyama
791-0280
Japan
New Taipei City
10002
Taiwan
Changhua City
500
Taiwan
Kaohsiung City
807
Taiwan
5777 E Mayo Blvd.
Phoenix
AZ
85054
USA
Davis Building
Jacksonville
FL
32224
USA
400 S. Orange Ave.
Orlando
FL
32806
USA
200 Hawkins Drive
Iowa City
IA
52242
USA
55 Fruit Street
Boston
MA
02114
USA
200 1st St SW
Rochester
MN
55905
USA
450 Lakevill Rd.
Hyde Park
NY
11042
USA
20 Duke Medicine Cir
Durham
NC
27710
USA
719 Manning St.
Philadelphia
PA
19106
USA
3410 Worth Street
Dallas
TX
75246
USA
12200 West 110th Street,
Overland Park
KS
66210
USA
2020 Santa Monica Blvd Suites 230, 580 & 600
Santa Monica
CA
90404
USA
8700 Beverly Blvd.
Los Angeles
CA
90048
USA
35 Park St
New Haven
CT
06511
USA
300 W. 10th Ave.
Columbus
OH
43210
USA
4500 Forest Park Avenue
St. Louis
MO
63108
USA
160 East 53rd Street
New York
NY
10022
USA
1240 Lee St.
Charlottesville
VA
22908
USA
The Alfred Hospital
Melbourne
VIC
3004
Australia
UZ Herestraat 49
Leuven
3000
Belgium
Av. Trinta e Um, 667 - Centro, Barretos - SP, 14780-360, Brazil
Barettos
Sao Paulo
14748-400
Brazil
Montreal
QC
H4A 3J1
Canada
Beijing
100036
China
Jinan
Shandong
250021
China
229 Cours Argonne
Bordeaux
Gironde
33076
France
3 Rue Frédéric Combemale
Lille
Nord
59000
France
28 rue Laennec
Lyon
Rhone
69373
France
Saint-Herblain
Loire Atlantique
44805
France
Villejuif
Val de Narne
94805
France
Schwanebecker Chaussee
Berlin
Germany
Candiolo
10060
Italy
via Giacomo
Milan
20133
Italy
Palermo
90127
Italy
Roma
00128
Italy
Meldola
FC
47014
Italy
Geert Grooteplein Zuid 10
Nijmegen
Gelderland
6525 GA
Netherlands
Ullernchausseen 70
Oslo
0379
Norway
Roentgena 5
Warsaw
02-781
Poland
807 Hoguk-ro, Buk-gu
Daeugu
41404
Republic of Korea
Seoul
03080
Republic of Korea
50 Yonsei-Ro
Seoul
120-752
Republic of Korea
Seoul
138-736
Republic of Korea
Carrer de Sant Antoni Maria Clare, 167
Barcelona
08025
Spain
Madrid
28040
Spain
Av. Manuel Siurot, S/n
Sevilla
41013
Spain
Valencia
46009
Spain
Zaragosa
50009
Spain
Madrid
28040
Spain
Kaohsiung
83301
Taiwan
Cambridge
CB2 OQQ
UK
Whitham Rd, Broomhall
Sheffield
S10 2SJ
UK
235 Euston Road
London
NW1 2BU
UK