NCT05028478

A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

An Open-Label, Multi-center, Phase I/II Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Curon Biopharmaceutical (Australia) Co Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Locally Advanced Solid Tumor
• Metastatic Solid Tumor
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	CN202	Participants will receive CN202 by IV infusion on Day 1 of each cycle (once every 2 weeks). The 4 planned dose levels are 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg

Timeline

• Start date: 2021-10-22
• Primary completion: 2023-02-10
• Completion: 2023-10-06
• First posted: 2021-08-31
• Last updated: 2021-08-31