Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

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