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A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Summary
This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22\~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
Official title: A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2024-03-12
Completion Date
2025-05-31
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
IBI129
Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
Locations (7)
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
St George private Hospital
Kogarah, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Tianjin Medical university cancer institute & Hospital
Tianjin, Tianjin Municipality, China