This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers.
A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers
Advanced Solid Tumors, Including But Not Limited to Lung CancerHead and Neck CancerPancreatic CancerOvarian CancerRenal Cell CarcinomaMalignant GliomaNivolumab
You can join if…
Open to people ages 18 years and up
Patients must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
Patients must have had progressive disease on, after, or refused, appropriate approved therapy for their tumor type.
Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
ECOG performance status of 0 or 1
Willing and able to comply with all study procedures
You CAN'T join if...
Current or history of clinically significant muscle disorders (e.g., myositis),recent unresolved muscle injury, or any condition known to elevate serum CK levels
Decreased cardiac function with NYHA> Class 2
Uncontrolled or significant heart disorder such as unstable angina
Significant abnormalities on ECG at screening. QTcF>450 msec for males or>470 msec for females at screening
History of anti-drug antibodies, severe allergic, anaphylactic, or other infusion-related reaction to a previous biologic agent
Positive test for latent tuberculosis (TB) at screening (Quantiferon test) or evidence of active TB
Patients with abnormal serum chemistry values, which in the opinion of the Investigator is considered to be clinically significant, will be excluded from the study
Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
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
Pregnant or breastfeeding
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 pose a risk to patient safety
Prior exposure to any CSF1R pathway inhibitors
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