Informations générales (source: ClinicalTrials.gov)
A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1]
Interventional
Phase 1
IDRx, Inc. (Voir sur ClinicalTrials)
août 2022
septembre 2026
15 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hopitaux de Marseille - Hopital de La Timone - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Bergonie unicancer- Nouvelle Aquitaine - L'Institut Bergonie - 33076 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte Contre le Cancer (CLLC) - Universite de Lyon -Centre Leon-Berard - 69008 - Lyon - Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.
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. Primary brain 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.