Description:
This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and
clinical benefit of Cabiralizumab in combination with nivolumab in patients with selected
advanced cancers.
Title
- Brief Title: Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
- Official Title: A Phase 1a/1b Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Clinical Trial IDs
- ORG STUDY ID:
FPA008-003
- NCT ID:
NCT02526017
Conditions
- Advanced Solid Tumors, Including But Not Limited to Lung Cancer
- Head and Neck Cancer
- Pancreatic Cancer
- Ovarian Cancer
- Renal Cell Carcinoma
- Malignant Glioma
Interventions
Drug | Synonyms | Arms |
---|
FPA008 | anti-CSF-1R (Anti-colony stimulating factor-1 receptor), Cabiralizumab | Phase 1 a monotherapy dose escalation |
BMS-936558 | anti-PD-1 (anti-programmed-death-1), MDX-1106, Nivolumab | Phase 1a combination therapy dose escalation |
Purpose
This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and
clinical benefit of Cabiralizumab in combination with nivolumab in patients with selected
advanced cancers.
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1 a monotherapy dose escalation | Experimental | FPA008: specified dose on specified days | |
Phase 1a combination therapy dose escalation | Experimental | FPA008 + BMS-936558: specified dose on specified days | |
Phase 1b combination therapy dose expansion | Experimental | FPA008 + BMS-936558: specified dose on specified days | |
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 RECIST v1.1 criteria.
- Patients must have had progressive disease on, after, or refused, appropriate approved
therapy for their tumor type.
- Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
- 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 CK levels
- Decreased cardiac function with NYHA > Class 2
- Uncontrolled or significant heart disorder such as unstable angina
- Significant abnormalities on ECG at screening. 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 CSF1R pathway inhibitors
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety: Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and clinical laboratory abnormalities defined as Dose Limiting Toxicities (Phase 1a) |
Time Frame: | 20 weeks |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Efficacy: Overall survival (OS) including median OS and one-year OS, duration of response (DOR), and progression free survival (PFS) (Phase 1b) |
Time Frame: | 52 weeks |
Safety Issue: | |
Description: | |
Measure: | PK parameters of cabiralizumab : Area under the curve (AUC), clearance (CL), maximum observed concentration (Cmax), minimum observed concentration (Cmin), and volume of distribution at steady state (Vss). (Phase 1a and 1b) |
Time Frame: | 52 weeks |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity of cabiralizumab: Analysis of anti-FPA008 antibody level in serum (Phase 1a and 1b) |
Time Frame: | 52 weeks |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity of nivolumab: Analysis of anti-nivolumab antibody level in serum (Phase 1a and 1b) |
Time Frame: | 52 weeks |
Safety Issue: | |
Description: | |
Measure: | PD biomarkers: Changes in macrophage and T-cell levels based on expression of CD68 and CD8 in tumor biopsy samples, changes in cytokine levels by multiplex analysis, and changes in whole blood monocyte subsets (Phase 1a and 1b) |
Time Frame: | 52 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Five Prime Therapeutics, Inc. |
Last Updated
July 31, 2020