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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||March 27, 2018||Early Phase 1||Interventional|
Primary Outcome 1 - Measure: For Phase 1a, to determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of FPA150
Primary Outcome 1 - Time Frame: Through study completion, an average of 24 weeks
Primary Outcome 2 - Measure: For Phase 1a, number of participants with adverse events as assessed by the latest version of CTCAE
Primary Outcome 2 - Time Frame: Through study completion, an average of 24 weeks
Primary Outcome 3 - Measure: For Phase 1b, number of participants with adverse events as assessed by the latest version of CTCAE at the maximum tolerated dose (MTD) and/or recommended dose (RD) of FPA150
Primary Outcome 3 - Time Frame: Through study completion, average 24 weeks
- Histologically confirmed solid tumors except primary central nervous system (CNS)
- Disease that is unresectable, locally advanced, or metastatic.
- Patients must have had progressive disease during or after, or refused, appropriate
standard therapy for their tumor type.
- All patients must have at least one measurable lesion at baseline according to RECIST
v1.1; tumor sites situated in a previously irradiated area, or in an area subjected to
other loco-regional therapy, are not considered measurable unless there has been
demonstrated progression in the lesion.
- Adequate washout for prior anti-cancer therapy (ie, ≥ 5 half-lives or 4 weeks since
the last dose, whichever is shorter).
- Availability of archival tumor tissue and consent to providing archival tumor for
retrospective biomarker analysis, or willingness to undergo a fresh tumor biopsy
during screening (a biopsy is required for patients in the Phase 1a Dose Exploration
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Prior radiotherapy must be completed at least 2 weeks before the first dose of study
- Prior radiopharmaceuticals (eg strontium, samarium) must be completed at least 8 weeks
before the first dose of study drug.
- Screening laboratory values must meet the following criteria:
- Neutrophils ≥ 1200 cells/ µL
- Platelets ≥ 75 × 103/ µL
- Hemoglobin (Hb) ≥ 9.0 g/dL
- Serum creatinine < 1.5× ULN or creatinine clearance (CrCl) of ≥ 40 mL/ minute
- AST and ALT < 3× ULN
- Bilirubin < 1.5× ULN (except patients with Gilbert's syndrome, who must have
total bilirubin < 3 mg/dL)
- 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
- 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
Minimum Age: 18 Years
Maximum Age: 99 Years
Healthy Volunteers: No
Name: Sandeep Inamdar
Phone: (866) 588-3796
Scottsdale, Arizona 85258
Jasgit Sachdev, MD
Los Angeles, California 90095
Zev A Wainberg, MD
|Sarcoma Oncology Research Center
Santa Monica, California 90403
Sant P Chawla, MD
|Yale Cancer Center
New Haven, Connecticut 06520
Patricia LoRusso, DO
|Sarah Cannon Research Institute
Nashville, Tennessee 37203
Todd Bauer, MD
|The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Shubham Pant, MD
|South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
Amita Patnaik, MD