CompletedPhase 1NCT02526017

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

StatusCompleted
PhasePhase 1
U.S. locations39
SponsorFive Prime Therapeutics, Inc.
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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