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A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Summary
This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects with advanced, refractory solid malignancies or lymphomas.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-08-22
Completion Date
2026-12-31
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
IBI363
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Locations (4)
Kate.Wilkinson1@health.nsw.gov.au
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Sydney Southwest Private Hospital
Sydney, New South Wales, Australia
Cancer Care Wollongong
Sydney, New South Wales, Australia