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A FIRST-IN-HUMAN (FIH) STUDY OF IDRX-42 IN PARTICIPANTS WITH METASTATIC AND/OR UNRESECTABLE GASTROINTESTINAL STROMAL TUMORS (GIST)
EU CTIS ID: 2024-514930-19-00
What this study is testing
Phase 1: Determine the maximum tolerated dose (MTD) and/or recommended Phase 1b dose(s) and schedule(s) RP1bD(s) of IDRX-42 in participants with metastatic and/or surgically unresectable GIST Phase 1b: -Safety: Further characterize the safety and tolerability of IDRX-42 in participants with metastatic and/or surgically unresectable GIST - Efficacy: Evaluate the antitumor activity of IDRX-42 in participants with metastatic and/or surgically unresectable GIST Phase 1 and 1b: C-QTc Sub-Study: (at select sites in the US, UK, Belgium, Spain, and Germany) Evaluate the relationship between IDRX-42 plasma exposure and QT interval corrected by Fridericia’s formula (QTcF)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. ≥18 years of age, unless country specific standards require a different age for minors (e.g. ≥ 19 years of age in Korea).
- 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 1 measurable lesion by mRECIST v1.1 for participants with GIST (Demetri 2013).
- 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- 1. Any prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination (except for participants treated in Cohort 4 of Phase 1b).
- 2. GIST that is both KIT and PDGFRA wild-type.
- 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. Please refer to the study protocol for a complete list of exclusion criteria.
See the full eligibility criteria
- 1. ≥18 years of age, unless country specific standards require a different age for minors (e.g. ≥ 19 years of age in Korea).
- 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 1 measurable lesion by mRECIST v1.1 for participants with GIST (Demetri 2013).
- 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, or have resolved to baseline, at the time of first dose of study drug. Note: unresolved prior treatment-related Grade 2 alopecia, Grade ≥2 peripheral neuropathy, and Grade ≥2 hypothyroidism on a stable dose of thyroid hormone replacement therapy are allowed if deemed irreversible.
- 8. Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- 9. Additional Inclusion Criteria for Phase 1b Exploratory Cohorts: (1)For Cohort 1, progressed on imatinib only (second line therapy) and refused or are ineligible for other 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 ripretinib (fifth line or greater therapy). (3)For Cohort 3 [US, UK, China, and Japan only], treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies. Note: If a participant received imatinib in the adjuvant or neoadjuvant setting only, they would be considered eligible for Cohort 3 provided recurrence/progression with metastatic and/or unresectable disease occurred more than 6 months after the last dose of (neo)adjuvant imatinib. (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. Please refer to the study protocol for a complete list of inclusion criteria.
- 1. Any prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination (except for participants treated in Cohort 4 of Phase 1b).
- 2. GIST that is both KIT and PDGFRA wild-type.
- 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. Please refer to the study protocol for a complete list of exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Korea, Democratic People's Republic of
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Korea, Democratic People's Republic of; China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.