NCT07339748

A Clinical Study of ZL-85FA Tablets

An Open-label, Multicenter Phase I/IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ZL-85FA Tablets in Treating Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An open-label, multicenter phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZL-85FA tablets in treating advanced solid tumors

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ZL-85FA tablets	ZL-85FA tablets 2.5mg, oral, once daily
DRUG	ZL-85FA tablets	ZL-85FA tablets 5mg, oral, once daily
DRUG	ZL-85FA tablets	ZL-85FA tablets 10mg, oral, once daily
DRUG	ZL-85FA tablets	ZL-85FA tablets 15mg, oral, once daily
DRUG	ZL-85FA tablets	ZL-85FA tablets 20mg, oral, once daily
DRUG	ZL-85FA tablets	ZL-85FA tablets 25mg, oral, once daily
DRUG	ZL-85FA tablets	ZL-85FA tablets 30mg, oral, once daily
DRUG	ZL-85FA tablets	Based on the results obtained from the dose escalation phase, the necessity and dosage of the IIa phase expansion cohort will be determined by the Drug Safety Review Committee (SMC) after discussion.
DRUG	ZL-85FA tablets	Based on the results obtained from the dose escalation phase, the necessity and dosage of the IIa phase expansion cohort will be determined by the Drug Safety Review Committee (SMC) after discussion.

Timeline

• Start date: 2026-06-30
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2026-01-14
• Last updated: 2026-01-15

Locations

1 site across 1 country: China