NCT06694480

Study of FID-022 in Participants With Advanced Solid Tumors

A First-in-Human Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FID-022 as Monotherapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fulgent Pharma LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase I Clinical Trial is to evaluate the safety and tolerability of FID-022 in patients with advanced solid tumors.

Detailed description

FID-022-001 is a Phase 1, multicenter, open label dose escalation clinical study of FID-022 as monotherapy. FID-022 is composed of topoisomerase inhibitors encapsulated with a polyethyloxazoline material. The study drug is administered through intravenous route. Patients with advanced solid tumor diagnosis without standard curative treatments are the target population (please see the eligibility section)

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	FID-022	Advanced solid tumors

Timeline

• Start date: 2025-07-03
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-11-19
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study