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

NCT07313202 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-SOLID-II-004
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Response rate to adverse reactions during the treatment cycle

  In the study, treatment was administered on day 30 after the last dose.

• Discontinuation rate due to irAE

  Follow-up visits were conducted every 30 days from the last dose of treatment until 90 days.

Study Arms (2)

Treatment group 1：Subjects who developed resistance or dependence to hormone therapy

EXPERIMENTAL

Drug: Ivarmacitinib

Treatment group 2：Subjects whose irAE has resolved to Grade ≤1

EXPERIMENTAL

Drug: Ivarmacitinib

Interventions

Ivarmacitinib DRUG

8 mg, orally, once daily. Cohort 1: Continue dosing until irAE resolves to ≤ Grade 1, with a maximum treatment duration of 28 days.

Treatment group 1：Subjects who developed resistance or dependence to hormone therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• ECOG performance status score 0-1.
• Expected survival ≥ 12 weeks.
• Solid tumor patients who have discontinued treatment with immune checkpoint inhibitors (ICIs).
• Treatment with ICIs may be administered as monotherapy or in combination with other therapies (including but not limited to radiotherapy, chemotherapy, targeted therapy, etc.).
• Current Status of irAE:
• Cohort I:
• Patients currently diagnosed with steroid-resistant or steroid-dependent immune-related adverse events (immune myocarditis, immune colitis, immune myositis-arthritis, immune skin reactions, immune hepatitis, etc.);
• Patients with contraindications to steroid use, or who refuse continued steroid therapy due to adverse reactions following steroid administration.
• Cohort II:
• Patients discontinued immunotherapy due to irAE (CTCAE 5.0) after receiving ≥1 line of treatment including ICIs;
• Time since discontinuation of immunotherapy due to irAE ≤3 months;
• irAE has resolved to ≤Grade 1.
• The patient still possesses certain organ and bone marrow functions:
• Cohort 1:

You may not qualify if:

• \) Individuals with allergic diseases, a history of severe drug allergies, or potential hypersensitivity to Ivarmacitinib or its components; 2) Patients diagnosed with an embolic event within 3 months prior to enrollment, excluding superficial venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency); 3) Patients with severe non-irAE-related cardiac, hepatic, renal, or systemic diseases; 4) Patients with active tuberculosis or who received live vaccines during the illness period; 5) Patients with uncontrolled infectious diseases; 6) Patients with moderate to severe heart failure (NYHA Class III/IV); 7) Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) exceeding 500 IU/mL or 1000 copies per milliliter (cps/mL); Hepatitis C virus (HCV) antibody (HCV-Ab) positive with HCV RNA quantitative levels exceeding the upper limit of normal for the assay; HIV antibody (Anti-HIV) positive; active syphilis. Meeting any one of the above criteria.
• \) Previous treatment with JAK inhibitors prior to enrollment (for Cohort 1: ≤30 days of prior JAK inhibitor use, irAE resolution ≤ Grade 1, and investigator assessment permitting ICI restart; eligible for Cohort 2); 9) Cohort 2 participants with prior ICI restart therapy, including but not limited to PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, etc.; 10) Patients receiving intravenous biologic therapy for other baseline autoimmune diseases; 11) Pregnant or lactating females, and males or females unwilling to use contraception; 12) Psychiatric disorders impairing study compliance; 13) Subjects deemed unsuitable for this study by the investigator shall be excluded, such as those judged to have other factors that may necessitate premature termination of the study. These include: - Concurrent treatment for other serious illnesses (including psychiatric disorders) - Severe laboratory abnormalities - Family or social circumstances that may compromise subject safety or interfere with data/sample collection.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Interventions

ivarmacitinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 26, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share