Clinical Trial

Ivarmacitinib in Advanced Solid Tumors: A Prospective, Two-Cohort, Two-Phase Exploratory Study in Patients Discontinued Due to Immune Intolerance

Not Yet Recruiting Phase 2
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Summary
This study is a Phase II, two-cohort, multicenter, two-stage clinical trial. It plans to enroll 72 subjects with solid tumors who discontinued prior ICI therapy due to irAE. Cohort 1 enrolls subjects with irAE resistant to or dependent on corticosteroid therapy. Subjects in Cohort 1 who achieve ≤ Grade 1 irAE resolution following treatment may then enroll in Cohort 2. Cohort 2 enrolls subjects with irAE achieving ≤ Grade 1 resolution following treatment, and deemed eligible for ICI re-initiation by the investigator. Phase I is the safety run-in phase, enrolling 6 subjects per cohort. Phase II is the expansion phase, enrolling 30 subjects per cohort.
Trial Details
NCT Number NCT07313202
Lead Sponsor Fujian Cancer Hospital
Conditions Patients With Advanced Solid Tumors Who Discontinued Treatment Due to irAE
Enrollment 72 participants
Start Date 2025-12-10
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-26 (estimated)
Updated on ClinicalTrials.gov 2025-12-31