NCT05982080

A Study to Investigate FP002 in Subjects With Advanced Malignancies

A Phase 1 Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP002 in Subjects With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Guangdong Fapon Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.

Detailed description

This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor. The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile, immunogenicity, and preliminary anti-tumor activity of FP002 in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	FP002 Injection	Up to 6 FP002 dose levels (0.3, 1.0, 3.0, 10, 20, 30 mg/kg administered intravenously may be evaluated. Subjects will receive weekly infusions of FP002 until disease progression, unacceptable toxicity, consent withdrawal, physician decision, or start of subsequent anticancer therapy, whichever occurs first.

Timeline

• Start date: 2023-08-02
• Primary completion: 2025-04-01
• Completion: 2026-07-01
• First posted: 2023-08-08
• Last updated: 2023-08-25

Locations

3 sites across 1 country: China