SAR439459

DRUG3 trials

Sponsors

Sanofi

Conditions

Malignant Solid TumorOsteogenesis ImperfectaPlasma Cell Myeloma Refractory

Phase 1

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

CompletedNCT03192345

SanofiMalignant Solid Tumor

Start: 2017-06-09End: 2022-01-17Updated: 2024-08-07

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

RecruitingNCT04643002

SanofiPlasma Cell Myeloma Refractory

Start: 2021-01-25End: 2028-04-20Target: 258Updated: 2026-03-30

Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)

TerminatedNCT05231668

SanofiOsteogenesis Imperfecta

Start: 2022-08-25End: 2024-11-12Updated: 2025-09-11

Related Papers

Abstract CT046: Clinical and translational study of the TGF-β monoclonal antibody SAR439459 in combination with the PD-1 inhibitor cemiplimab for patients (pts) with advanced solid tumors: Results from the phase 1b TACTIC trial

Cancer Research2025-04-25

The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments.

2024-07-243 citations

Biomarker and pharmacodynamic activity of the transforming growth factor‐beta (<scp>TGFβ)</scp> inhibitor <scp>SAR439459</scp> as monotherapy and in combination with cemiplimab in a phase I clinical study in patients with advanced solid tumors

Clinical and Translational Science2024-02-016 citations

New advances in cancer therapy targeting TGF-β signaling pathways

Molecular Therapy — Oncolytics2023-12-0127 citations

30-Minute Infusion of Isatuximab in Newly Diagnosed Multiple Myeloma (NDMM) Patients: Results of a Phase 1b Study

Blood2023-11-022 citations

Safety and efficacy results from the expansion phase of the first-in-human study evaluating TGFβ inhibitor SAR439459 alone and combined with cemiplimab in adults with advanced solid tumors.

Journal of Clinical Oncology2022-06-0114 citations

520 Preliminary biomarker and pharmacodynamic (PD) activity of the TGFβ inhibitor SAR439459, alone or in combination with cemiplimab, in a phase 1 clinical study in patients with advanced solid tumors

Regular and Young Investigator Award Abstracts2021-11-013 citations

Abstract 1909: Pan-TGF-β inhibition with PD-1 blockade as a combination treatment strategy to augment anti-tumor immune response in hepatocellular carcinoma

Cancer Research2021-07-01

Safety, pharmacokinetic and pharmacodynamic results from dose escalation of SAR439459, a TGFβ inhibitor, as monotherapy or in combination with cemiplimab in a phase 1/1b study.

Journal of Clinical Oncology2021-05-205 citations

Abstract 773: Tumor-derived Extracellular Vesicles (EVs) expressing TGFb as potential biomarkers for anti-TGFb antibody activity and drug activity in liquid biopsy

Cancer Research2020-08-15

Pan-TGFβ inhibition by SAR439459 relieves immunosuppression and improves antitumor efficacy of PD-1 blockade

OncoImmunology2020-01-0153 citations

Abstract 5550: Translational biomarkers for SAR439459, an anti-TGFβ antibody for cancer immunotherapy

Cancer Research2018-07-013 citations