Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.
Checked against the public recordLast updated Mar 9, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Five Prime Therapeutics, Inc.
- Interventions being studied
- Biological: Cabiralizumab; Biological: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Scottsdale Healthcare Hospitals DBA Honor HealthScottsdale, Arizona
- Moores UC San Diego Cancer CenterLa Jolla, California
- Norris Comprehensive Cancer Center, University of Southern CaliforniaLos Angeles, California
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer CenterLos Angeles, California
- UC Davis Comprehensive Cancer CenterSacramento, California
- University of California, San FranciscoSan Francisco, California
- Sarcoma Oncology Research CenterSanta Monica, California
- UCLA Hematology/Oncology- Santa MonicaSanta Monica, California
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
- H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida
- Emory University HospitalAtlanta, Georgia
- Rush University Medical CenterChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 9, 2022. Always confirm current availability with the study team.