NCT05425602

A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors

A I / II Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetic Characteristics and Efficacy of MAX-40279 (Multi-target Tyrosine Kinase Inhibitor) Combined With KN046 (Anti-PD-L1 / CTLA-4 Bispecific Antibody) in Patients With Advanced / Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Maxinovel Pty., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This include two parts, Stage 1 is a dose climbing study and Stage 2 is a dose extending study.

Detailed description

This study is a study of MAX-40279 in patients with advanced / metastatic solid tumors. This study include two Parts, the Part 1 will assess the safety and efficacy of the dose climbing level of MAX-40279, and recommend a dose extending level of MAX-40279 for stage 2.

Conditions

• Advanced / Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	MAX-40279-01: 50mg/70mg	\[Stage 1\]The starting dose of MAX-40279 was 35 mg BID, and three dose levels were initially set: 35 mg, 50 mg, and 70 mg administered twice daily (BID) continuously, and the dose of KN046 was 5 mg/kg as a fixed dose administered every 3 weeks. \[Stage 2\]When the RP2D dose is obtained in the dose-finding phase, the trial will enter the dose expansion phase.

Timeline

• Start date: 2022-07-31
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2022-06-21
• Last updated: 2022-06-21