Immuno-PET imaging for advanced solid tumors using a new drug
A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab
This study is testing a new imaging drug to see if it can help doctors learn more about advanced solid tumors and how the immune system responds to treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor, immunotherapy, cemiplimab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05259709 on ClinicalTrials.gov |
What this trial studies
This study investigates the experimental imaging agent 89Zr-DFO-REGN5054 in combination with cemiplimab for patients with advanced or metastatic solid tumors. The primary focus is to assess the safety and tolerability of the imaging agent while exploring its potential to reveal important tumor features that may influence immune responses against cancer. Participants will undergo monitoring for side effects, blood concentration levels of the drug, and the body's immune response to the treatment. The study aims to enhance the understanding of how this imaging technique can aid in cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced or metastatic solid tumors that may respond to PD-1 immunotherapy and meet specific health criteria.
Not a fit: Patients currently receiving other cancer treatments or those with certain types of brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the ability to visualize tumors and enhance the effectiveness of immunotherapy in cancer treatment.
How similar studies have performed: While this approach is innovative, similar studies using immuno-PET imaging have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Groningen
- UMC Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.