A First-In-Human study of 89ZR-DFO-REGN5054 (anti-CD8) Positron Emission Tomography in patients with solid malignancies treated with cemiplimab

Recruiting

• Conditions: cancer; tumor; 10027655

• Registration Number: NL-OMON53715
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Advanced or metastatic solid tumors that may respond to anti-programmed cell
death 1 (PD-1) immunotherapy
2. Measurable disease according to Response Evaluation Criteria in Solid
Tumours (RECIST) 1.1 criteria
3. Eastern Cooperative Oncology Group (ECOG) performance status of <=1
4. Adequate organ and bone marrow function as defined in the protocol
5. Willing and able to comply with clinic visits and study-related procedures
(including required tumor biopsy for Part B
NOTE: Other protocol defined inclusion criteria apply.

Exclusion Criteria

1. Currently receiving another cancer treatment in another studyor inadequate
time since last therapy, as defined in the protocol
2. Has not yet recovered from acute toxicities from prior therapy; exceptions
defined in the protocol
3. Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1)
pathway
4. Currently receiving or has received chimeric antigen receptor (CAR-T) cell
therapy
5. Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal
cord compression
6. Known history of or any evidence of interstitial lung disease, active,
noninfectious pneumonitis (past 5 years) or active tuberculosis

PLEASE NOTE: ADDITIONAL EXCLUSION CRITERIA APPLY AND ARE OUTLINED IN THE
PROTOCOL

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The co-primary endpoints are:<br /><br>-For Part A, the primary endpoint is the incidence of treatment-emergent<br /><br>adverse events (TEAEs).<br /><br>-For Part A and B, the incidence and severity of TEAEs.</p><br>