CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 40 target
Drug / intervention
AL58805drug
Likely dose
AL58805 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT07179081Phase 1RecruitingMonitorUpdated 9mo ago · Completion was 5mo ago
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Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors

Advenchen Laboratories Nanjing Ltd.·interventional·Posted Sep 17, 2025·Updated Sep 17, 2025

In Brief

A Phase 1 clinical trial evaluating AL58805 for Advanced Tumors. Currently recruiting, targeting 40 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Tumors
CountriesChina
Collaborators--

Timeline

Phase 1RecruitingOverdue
202120222023202420252026
First PostedSep 17, 2025
Enrollment StartDec 20, 2020
Primary CompletionJan 26, 2026
TodayJul 1, 2026
Enrollment to primary: 5.1 yearsPosted 9 months ago

Interventions

AL58805drug

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