Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers

Study ID
STU 112015-068

Study Sites

  • Zale Lipshy University Hospital

Contact
Joyce Bolluyt
214/648-7007
joyce.bolluyt@utsouthwestern.edu

Principal Investigator
Muhammad Beg, M.D.

Official Title

A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers

Brief Overview

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.

Eligibility

Inclusion Criteria:
- 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
Exclusion Criteria:
- 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