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
Public ClinicalTrials.gov record NCT03192345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors
Study identification
- NCT ID
- NCT03192345
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Sanofi
- Industry
- Enrollment
- 161 participants
Conditions and interventions
Conditions
Interventions
- Cemiplimab REGN2810 Drug
- SAR439459 Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2017
- Primary completion
- Dec 20, 2021
- Completion
- Jan 16, 2022
- Last update posted
- Aug 6, 2024
2017 – 2022
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Kansas Clinical Research Center Site Number : 8400004 | Fairway | Kansas | 66205 | — |
| Massachusetts General Hospital Site Number : 8400001 | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute Site Number : 8400101 | Boston | Massachusetts | 02115 | — |
| Duke University Medical Center Site Number : 8400008 | Durham | North Carolina | 27710 | — |
| Tennessee Oncology, PLLC Site Number : 8400006 | Nashville | Tennessee | 37203 | — |
| Mary Crowley Cancer Research Center Site Number : 8400003 | Dallas | Texas | 75230 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03192345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2024 · Synced May 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03192345 live on ClinicalTrials.gov.