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ACTIVE NOT RECRUITING
NCT05290597
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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