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

A Phase 1a/1b 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.

This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of cabiralizumab in combination with nivolumab in patients with selected advanced cancers.

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