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NOT YET RECRUITING
NCT07622524
PHASE1

A Phase I Study of CS5007 in Participants With Advanced Solid Tumors

Sponsor: CStone Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

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