NCT07313202

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients With Advanced Solid Tumors Who Discontinued Treatment Due to irAE

Interventions

Type	Name	Description
DRUG	Ivarmacitinib	8 mg, orally, once daily. Cohort 1: Continue dosing until irAE resolves to ≤ Grade 1, with a maximum treatment duration of 28 days.
DRUG	Ivarmacitinib	Cohort 2: Combination therapy with ICIs, with a maximum treatment duration not exceeding the duration of ICI administration.

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-12-31
• Completion: 2028-12-26
• First posted: 2025-12-31
• Last updated: 2025-12-31