NCT05196360

MAX-10181 in Patients With Advanced Solid Tumor

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-10181 in Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Maxinovel Pty., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.

Detailed description

This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	MAX-10181	Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1.

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-01-01
• Completion: 2023-05-01
• First posted: 2022-01-19
• Last updated: 2022-01-19

Locations

1 site across 1 country: China