Clinical Trials

Date: 2018-03-28

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: Five Prime Therapeutics (USA - CA)

Product: FPA150

Action mechanism:

monoclonal antibody. FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast, bladder and gynecologic cancers, and has been documented to correlate with poor prognosis. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering potent ADCC against tumor cells expressing B7-H4.
B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Non-clinical data of FPA150 featured in an oral poster presentation at the European Society for Medical Oncology (ESMO) 2017 Congress described potent ADCC and T cell checkpoint blockade activity in vitro and significant dose-dependent anti-tumor efficacy in vivo.

Disease: advanced or metastatic breast, ovarian, endometrial and bladder cancers

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of FPA150, an anti-B7H4 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1b.(NCT03514121)

Latest news:

• On March 28, 2018, Five Prime Therapeutics announced that it initiated patient dosing in its Phase 1 clinical trial of FPA150, a first-in-class immuno-oncology antibody that targets B7-H4. Five Prime designed the Phase 1 trial of monotherapy FPA150 with a dose-escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels.
The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and bladder cancers. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.
• On January 3, 2018, Five Prime Therapeutics announced the December 2017 submission of an Investigational New Drug (IND) application for FPA150. Five Prime discovered FPA150 using the company's protein therapeutics platform and anticipates initiating a Phase 1 trial of FPA150 during the first half of 2018.
Five Prime designed the planned Phase 1 trial with a standard 3+3 dose escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and urothelial carcinomas.