NCT07179081

A Study of AL58805 in Patients With Advanced Tumors

Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I clinical trial is a dose-escalation, multicenter study in patients with advanced solid tumors. It includes tolerance studies of sequential multiple oral doses of AL58805 and pharmacokinetic studies of single and multiple doses, analyzing the tolerance range of multiple doses, observing the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in solid tumor patients, and assessing the reversibility of toxicity and the relationship between toxicity and dose.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
DRUG	AL58805	Oral,Multiple administrations, once or twice daily（20mg 、40mg QD; 20mg 、30mg、40mg、50mg、60mg BID；）

Timeline

• Start date: 2020-12-20
• Primary completion: 2026-01-26
• Completion: 2026-01-26
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: China