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A Study of AL58805 in Patients With Advanced Tumors

NCT07179081 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-17

No results posted yet for this study

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

DRUG

AL58805

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

Sponsors & Collaborators

  • Advenchen Laboratories Nanjing Ltd.

    lead INDUSTRY

Principal Investigators

  • Dongfang Li · Hunan Cancer Hospital

  • Yongchang Zhang · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-20
Primary Completion
2026-01-26
Completion
2026-01-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07179081 on ClinicalTrials.gov