Clinical trial · Interventional
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
NCT02526017CI-TRIAL-00057006FPA008-003completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabiralizumab | Biological | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1a Monotherapy Dose Escalation
- description
- Cabiralizumab administered at 2 mg/kg every 2 weeks (Q2W), 4 mg/kg Q2W and 6 mg/kg Q2W in participants with any solid tumor.
- interventionNames
- Biological: Cabiralizumab
- type
- EXPERIMENTAL
- label
- Phase 1a Combination Therapy Dose Escalation
- description
- Nivolumab 3 mg/kg Q2W + cabiralizumab at the following doses: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 6 mg/kg Q2W. Also nivolumab 3 mg/kg + cabiralizumab 4 mg/kg every 3 weeks (Q3W). Participants with any solid tumor.
- interventionNames
- Biological: Cabiralizumab
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.