A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors
Completed · Phase 1 · NCT03192345
Conditions: Malignant Solid Tumor
At a glance
- Research payments reported, 2025
- $11,716
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 161
About the trial
- Sponsor
- Sanofi
- Tested
- SAR439459 (biological), Cemiplimab REGN2810 (drug)
- Dates
- Started 2017-06-09; completion 2022-01-17
- Results posted
- Not yet
Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) * To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) * To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) * To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior thera…
From ClinicalTrials.gov, last updated 2024-08-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $11,716 in research payments for this study in 2025 (1 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Dana Farber Mass General Brigham Ca Care Inc $11,716
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.