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0C-15-4 A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers

Description

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.

Phase

Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.

Inclusion and Exclusion 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

  • 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

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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