deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT03192345

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

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

Sponsor: Sanofi

Conditions Malignant Solid Tumor
Interventions Cemiplimab REGN2810 SAR439459
Updated 42 times since 2017 Last updated: Aug 5, 2024 Started: Jun 9, 2017 Primary completion: Dec 21, 2021 Completion: Jan 17, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Malignant Solid Tumor and is currently completed. Sanofi leads this study, which shows 42 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Nov 2017 · 2 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Feb 2019 · 4 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Oct 2021 · 7 months · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Jun 2022 · 3 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

42 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE1

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

    Status: Terminated → Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  5. Jun 2022 — Jul 2024 [monthly]

    Terminated PHASE1

▶ Show 37 earlier versions

  1. Mar 2022 — Jun 2022 [monthly]

    Terminated PHASE1

    Status: Active Not Recruiting → Terminated

  2. Dec 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  3. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE1

  4. Mar 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  5. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1

  6. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  7. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  8. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1

  9. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE1

  10. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE1

  11. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE1

  12. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE1

  13. May 2020 — Jul 2020 [monthly]

    Recruiting PHASE1

  14. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE1

  15. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE1

  16. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1

  17. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1

  18. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE1

  19. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

  20. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE1

  21. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE1

  22. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1

  23. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

  24. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1

  25. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE1

  26. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE1

  27. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE1

  28. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE1

  29. Oct 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

  30. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE1

  31. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE1

  32. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE1

  33. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1

  34. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  35. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

  36. Sep 2017 — Nov 2017 [monthly]

    Recruiting PHASE1

  37. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE1

    First recorded

Jun 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sanofi
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barcelona, Spain , Boston, United States , Calgary, Canada , Cardiff, United Kingdom , Dallas, United States , Durham, United States , Essen, Germany , Fairway, United States , Glasgow, United Kingdom , Hanover, Germany and 18 more locations