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Clinical Trial Summary

The study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of CN202 in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies

Clinical Trial Description

This is a multi-centre, open-label, Phase I/II study in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies. The study consists of three parts Phase Ia: Dose Escalation: This is a dose escalation for assessment of dose-limiting toxicities (DLT) at approximately four dose levels in subjects with locally advanced or metastatic solid tumor or hematologic malignancies. Phase Ib: Dose Expansion: To evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CN202, prior to determination of Maximum tolerated dose (MTD) Phase II: To further evaluate the safety, tolerance, pharmacokinetic characteristics, and anti-tumor activity of CN202 in subjects with select tumors. All subjects will receive the recommended Phase II dose of CN202. There will be 13 to 24 subjects enrolled in phase Ia, 12 to 40 subjects in phase Ib and 15 to 100 subjects in phase II ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05028478
Study type Interventional
Source Curon Biopharmaceutical (Australia) Co Pty Ltd
Contact Danny Zhu
Phone +86 138-1074-9637
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 22, 2021
Completion date October 6, 2023

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