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
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Condition or disease | Intervention/treatment | Phase |
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Gastrointestinal Stromal Tumor (GIST) Digestive System Disease Gastrointestinal Diseases Metastatic Cancer | Drug: IDRX-42 | Phase 1 |
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 |
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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.
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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.
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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).
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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.
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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.
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Drug: IDRX-42
IDRX-42 will be administered at RP1bD(s) once or twice daily in continuous cycles of 28 days each. |
- 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 ]
- Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs) [ Time Frame: Approximately 18 months from first participant enrolled ]
- 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 ]
- Phase 1b-Number of participants with TEAEs and with laboratory test results [ Time Frame: Approximately 18 months ]
- Phase 1b - Objective Response Rate (ORR) mRESIST v1.1 [ Time Frame: Approximately 18 months ]
- Phase 1 (Dose Escalation)- Number of participants with non-DLT TEAEs and with laboratory test results [ Time Frame: 6 months ]
- Phase 1 (Dose Escalation) - ORR per mRECIST v1.1 [ Time Frame: 6 months ]
- 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) ]
- 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) ]
- 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) ]
- Phase 1 (Dose Escalation) - Duration of response (DOR) per mRECIST v1.1 [ Time Frame: 6 months ]
- Phase 1 (Dose Escalation) - Time to response (TTR) per mRECIST v1.1 [ Time Frame: 6 months ]
- Phase 1 (Dose Escalation) - Progression-free survival (PFS), per mRECIST v1.1 [ Time Frame: 6 months ]
- Phase 1b- Duration of response (DOR) per mRECIST v1.1 [ Time Frame: 18 months ]
- Phase 1b - PFS per mRECIST v1.1 [ Time Frame: 18 months ]
- Phase 1b - Clinical benefit rate (CBR) per mRECIST v1.1 [ Time Frame: 18 months ]
- Phase 1b - TTR per mRECIST v1.1 [ Time Frame: 18 months ]
- 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) ]
- 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) ]
- 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) ]
- Phase 1b - Overall survival [ Time Frame: 18 months ]
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- At least one measurable lesion by mRECIST v1.1 for participants with GIST
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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.
- 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
- For Cohort 1, progressed on imatinib only (second line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
- 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)
- For Cohort 3, treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
- 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:
- 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).
- GIST with no documented mutation in both KIT and PDGFRA genes.
- Any prior primary CNS malignancy or known untreated or active central nervous system metastases.
- Has an active uncontrolled infection, including, but not limited to, the requirement for intravenous antibiotics.
- Has significant, uncontrolled, or active cardiovascular disease.
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
Contact: IDRX Clinical Operations | 339-234-7028 | clinicaltrials@idrx.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
GIST IDRX IDRX-42 |
Strate StrateGIST StrateGIST 1 |
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 |