Phase 1
Completed N=313
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Source: ClinicalTrials.gov NCT02526017 ↗Enrolled (actual)
313
Serious AEs
50.3%
Results posted
Mar 2022
Primary outcomePrimary: Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) — 0; 0; 1; 0 Participants
Summary
Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a) |
4 | — |
| PRIMARY Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b) |
2; 10; 10; 4; 3; 264 | — |
| PRIMARY Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b) |
0; 12; 4; 8; 54 | — |
| PRIMARY Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b) |
6.9; 3.2; 13.8; 5.9; 13.3; 6.7 | — |
| SECONDARY Efficacy: Overall Survival (Phase 1b) |
12.3; 4.7; 6.4; 5.6; 13.9; NA | — |
| SECONDARY Efficacy: Overall Survival (OS) at One Year (Phase 1b) |
51.1; 29.2; 42.5; 27.2; 52.9; 77.8 | — |
| SECONDARY Efficacy: Duration of Response (Phase 1b) |
8.9; 16.2; NA; 12.7; 7.3; NA | — |
| SECONDARY Efficacy: Progression Free Survival (Phase 1b) |
2.8; 1.9; 1.8; 1.7; 2.0; 2.9 | — |
| SECONDARY Efficacy: Objective Response Rate - Central Review Assessment (Phase 1b) |
3.4; 0; 10.7; 6.0; 6.7; 16.7 | — |
| SECONDARY Pharmacokinetics (PK) of Cabiralizumab: Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose (Phase 1a and 1b) |
1.26; 1.70; 1.84; 0.66; 1.22; 1.66 | — |
| SECONDARY PK of Cabiralizumab: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) |
52.11; 104.82; 142.83; 21.93; 49.00; 104.47 | — |
| SECONDARY Immunogenicity of Cabiralizumab: Number of Participants With Anti-Cabiralizumab Antibodies (Phase 1a and 1b) |
0; 1; 0; 0; 0; 9 | — |
| SECONDARY Immunogenicity of Nivolumab: Number of Participants With Anti-Nivolumab Antibodies (Phase 1a and 1b) |
0; 0; 26; 0; 2; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02526017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.