deltatrials
Terminated PHASE1 INTERVENTIONAL 5-arm NCT05013554

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors.

Sponsor: Sanofi

Conditions Breast Cancer Gastric Cancer Lung Neoplasm Malignant Neoplasm Neoplasm Malignant
Interventions SAR443216 IV SAR443216 SC
Updated 22 times since 2021 Last updated: Sep 9, 2025 Started: Aug 16, 2021 Primary completion: Jan 15, 2024 Completion: Jan 15, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

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Listed as NCT05013554, this PHASE1 trial focuses on Breast Cancer and Gastric Cancer and remains terminated or withdrawn. Sponsored by Sanofi, it has been updated 22 times since 2021, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Jan 2022 · 3 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~May 2022 · 2 months · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Jun 2023 · 4 months · monthly snapshot~Jun 2023 – ~Sep 2023 · 3 months · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Jan 2024 · 3 months · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Dec 2025 · 2 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

22 versions recorded

  1. Dec 2025 — Present [monthly]

    Terminated PHASE1

  2. Oct 2025 — Dec 2025 [monthly]

    Terminated PHASE1

  3. Sep 2025 — Oct 2025 [monthly]

    Terminated PHASE1

  4. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1

  5. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

▶ Show 17 earlier versions

  1. Mar 2024 — Jul 2024 [monthly]

    Terminated PHASE1

    Status: Recruiting → Terminated

  2. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE1

  3. Oct 2023 — Jan 2024 [monthly]

    Recruiting PHASE1

  4. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1

  5. Jun 2023 — Sep 2023 [monthly]

    Recruiting PHASE1

  6. Feb 2023 — Jun 2023 [monthly]

    Recruiting PHASE1

  7. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE1

  8. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE1

  9. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE1

  10. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1

  11. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  12. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1

  13. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1

  14. Mar 2022 — May 2022 [monthly]

    Recruiting PHASE1

  15. Jan 2022 — Mar 2022 [monthly]

    Recruiting PHASE1

  16. Oct 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  17. Sep 2021 — Oct 2021 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Aug 2021

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