Drug: |
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Trial Name: |
A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Recruiting |
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Phase: |
1 |
Start Date 08/01/2022 |
Age of Trial (yrs) 1.2 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT/PDGFRA |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
IDRX-42-001 |
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Sponsor: |
IDRx, Inc. |
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Patient Contact: |
IDRX Clinical Operations 339-234-7028 clinicaltrials@idrx.com |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
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, after failure of at least imatinib due to progression of GIST. The study consists of 2 parts. Phase 1 comprises dose escalation to assess clinical and pharmacologic profile, safety/tolerability, and support choice of the recommended phase 2 dose and schedule (RP2DS). Phase 1b expansion will enroll separate cohorts of participants defined by numbers of lines of prior GIST therapy at the selected RP2DS to assess the preliminary antitumor effect of IDRX-42 and further characterize the safety profile of IDRX-42 at the RP2DS. Inclusion Criteria: Phase 1 Male or female participants ≥18 years of age Histologically or cytologically confirmed metastatic and/or surgically unresectable GIST Documented progression on imatinib (Phase 1) Documented pathogenic mutation in KIT OR any PDGFRA mutation other than exon 18 mutations, determined through local testing Exclusion Criteria: Any prior exposure to the following investigational agents NB003 or THE-630 or bezuclastinib plus sunitinib combination. GIST with no documented mutation in both KIT and PDGFRA genes. |
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 |
Name |
Address |
City |
State |
Zip |
Country |
450 Brookline Ave |
Boston |
MA |
02215-5450 |
USA |
|
333 Cottman Ave |
Philadelphia |
PA |
19111 |
USA |
|
1475 Northwest 12th Ave |
Miami |
FL |
33136 |
USA |
|
3181 S.W. Sam Jackson Park Rd. |
Portland |
OR |
97239 |
USA |