FPA150 in Patients With Advanced Solid Tumors

Stopped early · Early Phase 1

Conditions studied: Breast Cancer, Ovarian Cancer, Endometrial Cancer, Advanced Solid Tumors

In brief

This is a multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of FPA150, an anti-B7H4 antibody alone or in combination with pembrolizumab an anti-PD1 antibody in patients with advanced solid tumors. The Phase 1a, open-label, cohort will identify a recommended dose of FPA150 to use for Phase 1a Combination (FPA150 and Pembrolizumab) Safety Lead-in and for Phase 1b monotherapy cohorts.

Key facts

Study ID

NCT03514121

Run by

Five Prime Therapeutics, Inc.

People needed

95

Starts

2018-03-27

Expected to finish

2021-04-21

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent daily) must be discontinued at least 2 weeks before the first dose of study drug. Short courses of high dose steroids or continuous low dose (prednisone < 10 mg/day ) are allowed.
• Decreased cardiac function with New York Heart Association (NYHA) > Class 2 at screening.
• Uncontrolled or significant heart disorder such as unstable angina.
• QT interval corrected for heart rate (QTc) per institutional guidelines > 450 msec for males or > 470 msec for females at screening.
• Current unresolved infection or history of chronic, active, clinically significant infection (viral, bacterial, fungal, or other) which, in the opinion of the Investigator, would preclude the patient from exposure to a biologic agent or may pose a risk to patient safety.
• Any uncontrolled medical condition or psychiatric disorder which, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results.
• Active, known, or suspected autoimmune disease. Patients with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll.
• Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS).
• Positive test for hepatitis B virus surface antigen (HBsAg) or detectable hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection.
• Ongoing adverse effects from prior treatment > Grade 1 (with the exception of Grade 2 alopecia or peripheral neuropathy) based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
• Symptomatic interstitial lung disease or inflammatory pneumonitis.
• Untreated or active CNS or leptomeningeal metastases. Patients are eligible if metastases have been treated and patients are neurologically returned to baseline or neurologically stable (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks before the first dose of study drug.
• Evidence of coagulopathy or bleeding diathesis. Patients receiving stable therapeutic doses of anti-coagulants will be permitted.
• Transfusion of blood or platelets completed within 72 hours before the first dose of study drug.
• Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis
• For Cohort 1b1 only: Patients with HER2 positive disease

Where it is running

• Honor Health — Scottsdale, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Sarcoma Oncology Research Center — Santa Monica, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Orchard Healthcare Research Inc. — Skokie, Illinois, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Medical Oncology Associates, PS — Spokane, Washington, United States
• National Cancer Center — Gyeonggi-do, South Korea
• Seoul National University Bundang Hospital — Gyeonggi-do, South Korea
• Severance Hospital — Seoul, South Korea
• ASAN Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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