Patients With Selected Advanced Cancers Treatment Study
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.
Multiple cohorts for treatment:
NSCLC, pancreatic, renal, melanoma, ovarian, head and neck and malignant glioma cancers may qualify.
In order to participate you must meet the following criteria:
Have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
- Tumor sites used to satisfy this criterion must not have received any prior radiation therapy.
- Sites for biopsy must be distinct from target lesions used for efficacy assessment.
- Have had progressive disease on, or refused, appropriate approved therapy for their tumor type unless otherwise specified in the cohort specific criteria.
- Have had prior focal radiotherapy completed at least 2 weeks before first dose of study drug administration.
You will be excluded from the study if any of the following criteria apply to you:
- Have current or a history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
- Have uncontrolled or significant heart disorder such as unstable angina.
- Have had treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days prior to first dose of study drug administration or while on this study.
- Have had prior exposure to any CSF1R pathway inhibitors.
This is a partial list of inclusion and exclusion criteria.