Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers (FPA008-003)
Advanced Solid Tumors, Head and Neck Cancer, Pancreatic Cancer
About this trial
This is an interventional treatment trial for Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria:
- Patients must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Patients must have had progressive disease on, after, or refused, appropriate approved therapy for their tumor type.
- Patients must have histologically or cytologically confirmed solid tumor that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment
- Understand and sign an Institutional review board/Independent ethics committee (IRB/IEC)-approved informed consent form (ICF) prior to any study-specific evaluation
- Eastern Cooperative Oncology Group (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 creatine kinase (CK) levels
- Decreased cardiac function with New York Heart Association (NYHA) > Class 2
- Uncontrolled or significant heart disorder such as unstable angina
- Significant abnormalities on electrocardiogram (ECG) at screening. Fridericia's correction formula for QT interval (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 colony stimulating factor 1 receptor (CSF1R) pathway inhibitors
Sites / Locations
- Scottsdale Healthcare Hospitals DBA Honor Health
- Moores UC San Diego Cancer Center
- Norris Comprehensive Cancer Center, University of Southern California
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center
- UC Davis Comprehensive Cancer Center
- University of California, San Francisco
- Sarcoma Oncology Research Center
- UCLA Hematology/Oncology- Santa Monica
- Mount Sinai Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Emory University Hospital
- Rush University Medical Center
- University of Chicago Medical Center
- Indiana University Health Hospital
- University of Iowa Hospitals and Clinics
- Norton Cancer Institute, Norton Healthcare Pavilion
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Dana Farber Cancer Institute
- Karmanos Cancer Institute
- Henry Ford Hospital
- Allina Health, Virginia Piper Cancer Institute
- Roswell Park Cancer Institute
- Memorial Sloan Kettering
- The Christ Hospital
- Providence Portland Medical Center
- Oregon Health and Science University
- Hospital of the University of Pennsylvania
- Thomas Jefferson University Hospital
- University of Pittsburgh Cancer Institute, William M. Cooper Ambulatory Pavilion of the Hillman Cancer Center
- Hollings Cancer Center, Medical University of South Carolina
- Henry-Joyce Cancer Clinic, Vanderbilt-Ingram Cancer Center,
- Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center
- University of Texas Southwestern Medical Center
- Mischer Neuroscience Associates, The University of Texas Health Science Center at Houston
- The University of Texas MD Anderson Cancer Center
- Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio
- South Texas Accelerated Research Therapeutics, LLC
- Huntsman Cancer Institute
- Seattle Cancer Care Alliance
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Phase 1a Monotherapy Dose Escalation
Phase 1a Combination Therapy Dose Escalation
Phase 1b Combination Therapy Dose Expansion
Cabiralizumab administered at 2 mg/kg every 2 weeks (Q2W), 4 mg/kg Q2W and 6 mg/kg Q2W in participants with any solid tumor.
Nivolumab 3 mg/kg Q2W + cabiralizumab at the following doses: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 6 mg/kg Q2W. Also nivolumab 3 mg/kg + cabiralizumab 4 mg/kg every 3 weeks (Q3W). Participants with any solid tumor.
The expansion phase would use the recommended dose determined in Phase 1a: cabiralizumab 4 mg/kg + nivolumab 3 mg/kg Q2W. Participants are enrolled for the following advanced cancer types: non-small cell lung cancer (anti-programmed cell death 1 [PD1] targeted drug naïve), non-small cell lung cancer (prior treatment with anti-PD-1), pancreatic cancer, ovarian cancer, renal cell cancer, glioblastoma, and melanoma.