Trial Title:
A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1]
NCT ID:
NCT05489237
Condition:
Gastrointestinal Stromal Tumor (GIST)
Digestive System Disease
Gastrointestinal Diseases
Metastatic Cancer
Conditions: Official terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Diseases
Digestive System Diseases
Conditions: Keywords:
GIST
IDRX
IDRX-42
Strate
StrateGIST
StrateGIST 1
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IDRX-42
Description:
IDRX-42 will be administered at assigned doses and schedules once or twice daily in
continuous cycles of 28 days each.
Arm group label:
Dose Escalation (Phase I)
Intervention type:
Drug
Intervention name:
IDRX-42
Description:
IDRX-42 will be administered at RP1bD(s) once or twice daily in continuous cycles of 28
days each.
Arm group label:
(Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy
Arm group label:
(Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy
Arm group label:
(Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve
Arm group label:
(Phase 1b): Cohort 4
Summary:
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.
Detailed description:
This is a Phase 1/1b open-label, first-in-human FIH study of IDRX-42, an orally
administered small molecule tyrosine kinase inhibitor. Eligible participants will have
metastatic and/or surgically unresectable GIST. The study consists of 2 parts. Phase 1
comprises dose escalation to assess clinical and pharmacologic profile and
safety/tolerability after failure of at least prior imatinib and support choice of the
recommended phase 1b dose(s) and schedule(s) (RP1bDs)). Phase 1b expansion will enroll
separate cohorts of participants defined by numbers of lines of prior GIST therapy at the
selected RP1bD(s) to assess the preliminary antitumor effect of IDRX-42 and further
characterize the safety profile of IDRX-42 at the RP1bD(s).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Phase 1
1. Male or female participants ≥18 years of age
2. Histologically or cytologically confirmed metastatic and/or surgically unresectable
GIST
3. Documented progression on imatinib (Phase 1)
4. Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18
mutations, determined through local testing
5. At least one measurable lesion by mRECIST v1.1 for participants with GIST
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Resolution of any toxicities from prior treatment(s) to ≤ Grade 1 by NCI CTCAE v5.0
criteria, or have resolved to baseline, at the time of first dose of study drug.
8. Willing and able to comply with scheduled visits, drug administration plan,
laboratory tests, or other study procedures and study restrictions.
Additional for Phase 1b Exploratory Cohorts
1. For Cohort 1, progressed on imatinib only (second line therapy) and refused or are
ineligible for other standard of care (SOC) therapies.
2. For Cohort 2, progressed on both imatinib and sunitinib (third line therapy) or
progressed on imatinib, sunitinib, and an additional agent (i.e., regorafenib or
ripretinib) (fourth line therapy) or progressed on imatinib, sunitinib, regorafenib,
and ripretininb (fifth line or greater therapy)
3. For Cohort 3, treatment naïve (first line therapy) and refused or are ineligible for
other standard of care (SOC) therapies.
4. For Cohort 4, met the same criteria as Cohort 2 (third line or greater) and have
also had prior treatment with investigational agents NB003 or THE-630 or a line of
therapy of bezuclastinib plus sunitinib combination.
Exclusion Criteria:
1. Any prior exposure to the following investigational agents NB003 or THE-630 or
bezuclastinib plus sunitinib combination (except for participants treated in Cohort
4 of Phase 1b).
2. GIST with no documented mutation in both KIT and PDGFRA genes.
3. Any prior primary CNS malignancy or known untreated or active central nervous system
metastases.
4. Has an active uncontrolled infection, including, but not limited to, the requirement
for intravenous antibiotics.
5. Has significant, uncontrolled, or active cardiovascular disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Trent, MD
Phone:
305-243-8175
Email:
nxr518@med.miami.edu
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Suzanne George, MD
Phone:
617-632-5204
Facility:
Name:
Oregon Health & Science University (OHSU)
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Heinrich, MD
Phone:
503-494-1080
Email:
trials@ohsu.edu
Facility:
Name:
Temple University Health System (Temple Health) - Fox Chase Cancer Center (FCCC) - Main Campus
Address:
City:
Philadelphia
Zip:
19111-2497
Country:
United States
Status:
Recruiting
Contact:
Last name:
Margaret Von Mehren
Phone:
215-728-2814
Email:
margaret.vonmehren@fccc.edu
Facility:
Name:
The University of Texas - MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4000
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neeta Somaiah
Phone:
713-796-3626
Email:
NSomaiah@mdanderson.org
Facility:
Name:
Universitaire Ziekenhuizen (UZ) Leuven - Campus Gasthuisberg - Leuvens Kankerinstituut (Leuven Cancer Institute) (LKI)
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Patrick Schöffski
Phone:
+32 16 34 69 00
Email:
trialunit@uzleuven.be
Facility:
Name:
HELIOS Kliniken GmbH - HELIOS Klinikum Berlin-Buch
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Annette Reichardt
Phone:
+49 30 9401-14852
Email:
annette.reichardt@helios-gesundheit.de
Facility:
Name:
University Hospital Essen-West German Cancer Center
Address:
City:
Essen
Zip:
D - 45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sebastian Bauer
Phone:
+49 (0) 201 / 723 2112
Email:
sebastian.bauer@uk-essen.de
Facility:
Name:
Vall d' Hebron Institute of Oncology (VHIO)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Silvia Espino
Phone:
(+34) 93 274 60 00
Phone ext:
4920
Email:
silviahurtado@vhio.net
Start date:
August 1, 2022
Completion date:
September 13, 2026
Lead sponsor:
Agency:
IDRx, Inc.
Agency class:
Industry
Source:
IDRx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05489237
