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A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) [Study ID: StrateGIST 1]

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ClinicalTrials.gov Identifier: NCT05489237
Recruitment Status : Recruiting
First Posted : August 5, 2022
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
IDRx, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor (GIST) Digestive System Disease Gastrointestinal Diseases Metastatic Cancer Drug: IDRX-42 Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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]
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : April 24, 2026
Estimated Study Completion Date : September 13, 2026


Arm Intervention/treatment
Experimental: Dose Escalation (Phase I)
Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST.
Drug: IDRX-42
IDRX-42 will be administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.

Experimental: (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy
Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies.
Drug: IDRX-42
IDRX-42 will be administered at RP1bD(s) once or twice daily in continuous cycles of 28 days each.

Experimental: (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy
Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy).
Drug: IDRX-42
IDRX-42 will be administered at RP1bD(s) once or twice daily in continuous cycles of 28 days each.

Experimental: (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve
Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
Drug: IDRX-42
IDRX-42 will be administered at RP1bD(s) once or twice daily in continuous cycles of 28 days each.

Experimental: (Phase 1b): Cohort 4
Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination.
Drug: IDRX-42
IDRX-42 will be administered at RP1bD(s) once or twice daily in continuous cycles of 28 days each.




Primary Outcome Measures :
  1. Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs) [ Time Frame: When participant completes 1 cycle (28 days) treatment with safety and tolerability assessment by investigators ]
  2. Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs) [ Time Frame: Approximately 18 months from first participant enrolled ]
  3. Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42 [ Time Frame: Approximately 18 months from first participant enrolled ]
  4. Phase 1b-Number of participants with TEAEs and with laboratory test results [ Time Frame: Approximately 18 months ]
  5. Phase 1b - Objective Response Rate (ORR) mRESIST v1.1 [ Time Frame: Approximately 18 months ]

Secondary Outcome Measures :
  1. Phase 1 (Dose Escalation)- Number of participants with non-DLT TEAEs and with laboratory test results [ Time Frame: 6 months ]
  2. Phase 1 (Dose Escalation) - ORR per mRECIST v1.1 [ Time Frame: 6 months ]
  3. Phase 1 (Dose Escalation) - Cmax; Maximum Observed Concentration of IDRX-42 [ Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days) ]
  4. Phase 1 (Dose Escalation) - Tmax; Time of First Occurrence of Maximum Plasma Concentration (Cmax) of IDRX-42 [ Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days) ]
  5. Phase 1 (Dose Escalation) - AUC 0-24; Area Under the Concentration-time Curve from Time Zero to 24 hours for IDRX-42 [ Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days) ]
  6. Phase 1 (Dose Escalation) - Duration of response (DOR) per mRECIST v1.1 [ Time Frame: 6 months ]
  7. Phase 1 (Dose Escalation) - Time to response (TTR) per mRECIST v1.1 [ Time Frame: 6 months ]
  8. Phase 1 (Dose Escalation) - Progression-free survival (PFS), per mRECIST v1.1 [ Time Frame: 6 months ]
  9. Phase 1b- Duration of response (DOR) per mRECIST v1.1 [ Time Frame: 18 months ]
  10. Phase 1b - PFS per mRECIST v1.1 [ Time Frame: 18 months ]
  11. Phase 1b - Clinical benefit rate (CBR) per mRECIST v1.1 [ Time Frame: 18 months ]
  12. Phase 1b - TTR per mRECIST v1.1 [ Time Frame: 18 months ]
  13. Phase 1b - Cmax; Maximum Observed Concentration of IDRX-42 [ Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days) ]
  14. Phase 1b - Tmax; Time of First Occurrence of Maximum Plasma Concentration (Cmax) of IDRX-42 [ Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days) ]
  15. Phase 1b - AUC 0-24; Area Under the Concentration-time Curve from Time Zero to 24 hours for IDRX-42 [ Time Frame: At the end of Cycle 1 Day 1 and at the end of Cycle 2 Day 1 (each cycle is 28 days) ]
  16. Phase 1b - Overall survival [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05489237


Contacts
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Contact: IDRX Clinical Operations 339-234-7028 clinicaltrials@idrx.com

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Jonathan Trent, MD    305-243-8175    nxr518@med.miami.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Suzanne George, MD    617-632-5204      
United States, Oregon
Oregon Health & Science University (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Heinrich, MD    503-494-1080    trials@ohsu.edu   
United States, Pennsylvania
Temple University Health System (Temple Health) - Fox Chase Cancer Center (FCCC) - Main Campus Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Margaret Von Mehren    215-728-2814    margaret.vonmehren@fccc.edu   
United States, Texas
The University of Texas - MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4000
Contact: Neeta Somaiah    713-796-3626    NSomaiah@mdanderson.org   
Belgium
Universitaire Ziekenhuizen (UZ) Leuven - Campus Gasthuisberg - Leuvens Kankerinstituut (Leuven Cancer Institute) (LKI) Recruiting
Leuven, Belgium, 3000
Contact: Patrick Schöffski    +32 16 34 69 00    trialunit@uzleuven.be   
Germany
HELIOS Kliniken GmbH - HELIOS Klinikum Berlin-Buch Recruiting
Berlin, Germany, 13125
Contact: Annette Reichardt    +49 30 9401-14852    annette.reichardt@helios-gesundheit.de   
University Hospital Essen-West German Cancer Center Recruiting
Essen, Germany, D - 45147
Contact: Sebastian Bauer    +49 (0) 201 / 723 2112    sebastian.bauer@uk-essen.de   
Spain
Vall d' Hebron Institute of Oncology (VHIO) Recruiting
Barcelona, Spain, 08035
Contact: Silvia Espino    (+34) 93 274 60 00 ext 4920    silviahurtado@vhio.net   
Sponsors and Collaborators
IDRx, Inc.
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Responsible Party: IDRx, Inc.
ClinicalTrials.gov Identifier: NCT05489237    
Other Study ID Numbers: IDRX-42-001
StrateGIST 1 ( Other Identifier: IDRX, Inc. )
First Posted: August 5, 2022    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IDRx, Inc.:
GIST
IDRX
IDRX-42
Strate
StrateGIST
StrateGIST 1
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms