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A Phase I Study of CS5007 in Participants With Advanced Solid Tumors
Sponsor: CStone Pharmaceuticals
Summary
This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
Official title: A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2026-06
Completion Date
2029-01
Last Updated
2026-06-18
Healthy Volunteers
No
Conditions
Interventions
CS5007
CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Locations (7)
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China