JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC

Sponsor
Fudan University
Study ID
NCT06731153
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivarmacitinib — DRUG
    a selective Janus kinase 1 inhibitor
  • Camrelizumab (SHR-1210) — DRUG
    a humanised anti-programmed death-1 (anti PD-1) antibody
  • Eribulin — DRUG
    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.

Study Details

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

Key Dates

Start date
Dec 31, 2024
Status verified
Dec 2024
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety run-in
    Ivarmacitinib + Camrelizumab + Eribulin
  • Experimental: Treatment group
    Ivarmacitinib + Camrelizumab + Eribulin, RP2D
  • Active Comparator: Control group
    Ivarmacitinib + Eribulin, RP2D

Primary Outcome Measure

Safety run-in: Incidence rate of dose-limiting toxicities (DLTs) [ Time Frame: 21±3 days ]

Related Studies