NCT06731153

JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC

A Randomized, Controlled, Open-label, Phase II Clinical Study Evaluating the JAK1 Inhibitor Ivarmacitinib to Reverse Immunotherapy Resistance in Triple-negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, randomized phase II clinical study which recruits unresectable recurrent or metastatic triple-negative breast cancer resistant to immunotherapy.

Detailed description

This is a prospective, open-label, randomized phase II clinical study. The purpose of this study is to test the combination of the JAK1 inhibitor Ivarmacitinib and the PD-1 inhibitor Camrelizumab in patients with immunotherapy-resistant locally advanced inoperable or metastatic triple-negative breast cancer. The study included a safety run-in period to explore the safety of Ivarmacitinib in combination with Eribulin and Camrelizumab, which will provide a recommended dose for the triplet combination of Ivarmacitinib, Camrelizumab and Eribulin. The latter phase II period is set to compare the efficacy of the triplet combination of Ivarmacitinib, Camrelizumab and Eribulin versus Eribulin plus Ivarmacitinib.

Conditions

• Triple Negative Breast Cancer (TNBC)
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Ivarmacitinib	a selective Janus kinase 1 inhibitor
DRUG	Camrelizumab (SHR-1210)	a humanised anti-programmed death-1 (anti PD-1) antibody
DRUG	Eribulin	Eribulin is an anticancer drug approved for treatment of metastatic breast cancer. This drug is a synthetic derivative from Japanese marine sponge Halichondria okadai. It acts by interfering with the microtubular growth ultimately leading to apoptosis after prolonged mitotic blockage.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: China