NCT06990698

A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors

A Phase 1 First-In-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP008 in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Zhuhai Fapon Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the phase 1 study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics activity of FP008 in subjects with advanced solid tumors.

Detailed description

This is a first-in-human (FIH), multicenter, open-label, dose escalation and dose expansion Phase 1 study of FP008 injection in subjects with advanced solid tumors. This study will evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of FP008. The study consists two parts: Part 1 (dose escalation phase) will evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of FP008 treatment, and to estimate the DRDE(s) of FP008. Part 2 (Dose expansion phase) will evaluate the safety, tolerability, PK, PD, immunogenicity, and efficacy at the different DRDE(s)/schedule(s) of FP008 in subjects with selected advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	FP008 for injection	FP008 should be administered intravenous weekly. Six FP008 dose levels are planned to evaluated.

Timeline

• Start date: 2025-06-12
• Primary completion: 2028-05-01
• Completion: 2028-09-01
• First posted: 2025-05-25
• Last updated: 2025-10-02

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study