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