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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
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
CS5007
CS5007 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
Locations (3)
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China