First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors

Conditions

• Digestive System Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumor (GIST)
• Metastatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IDRX-42 — DRUG
  Administered at assigned doses and schedules once or twice daily in continuous cycles of 28 days each.

Study Details

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.

Key Dates

Start date

Aug 3, 2022

Status verified

Apr 2026

Primary completion

Mar 10, 2027

Completion

Jun 28, 2028

Study Design

Enrollment

278 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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).
• 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.
• 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.

Primary Outcome Measure

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 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (8)

Find similar trials in Miami, FL

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