Clinical trial · Interventional
A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab
A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This study is researching an experimental drug called 89Zr-DFO-REGN5054 and cemiplimab. The study is focused on patients with a type of cancer that can be potentially imaged using 89Zr-DFO-REGN5054 and show special tumor features that may be important to the way the immune system fights cancer. The aim of the study is to study the safety and tolerability (how the body reacts to the drug) of the imaging agent 89Zr-DFO REGN5054. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)
Conditions
Conditions (2)
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr˗DFO˗REGN5054 | Drug | — | UNRESOLVED |
| cemiplimab | Drug | Cemiplimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
- description
- Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
- interventionNames
- Drug: 89Zr˗DFO˗REGN5054
- Drug: cemiplimab
- type
- EXPERIMENTAL
- label
- Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
- description
- Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
- interventionNames
- Drug: 89Zr˗DFO˗REGN5054
- Drug: cemiplimab
Primary outcomes (2)
- measure
- Incidence and severity of treatment-emergent adverse events (TEAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (PD-1) immunotherapy * Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 * Adequate organ and bone marrow function as defined in the protocol * Willing and able to comply with clinic visits and study-related procedures (including required tumor biopsy for Part B) Key Exclusion Criteria: * Currently receiving another cancer treatment or inadequate time since last therapy, as defined in the protocol * Has not yet recovered from acute toxicities from prior therapy; exceptions defined in the protocol * Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1) pathway * Currently receiving or has received chimeric antigen receptor (CAR-T) cell therapy * Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression * Known history of or any evidence of interstitial lung disease, active, noninfectious pneumonitis (past 5 years) or active tuberculosis NOTE: Other protocol defined inclusion/exclusion criteria apply.
References
Publications (0)
Data not yet available