deltatrials
Recruiting PHASE1 INTERVENTIONAL 1-arm NCT04585958

Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer

A Phase I Study of DS-8201a in Combination With Olaparib in HER2-Expressing Malignancies

Sponsor: National Cancer Institute (NCI)

Conditions Metastatic Malignant Solid Neoplasm Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma Unresectable Malignant Solid Neoplasm
Interventions Biopsy Procedure Biospecimen Collection Computed Tomography Echocardiography Test Multigated Acquisition Scan Olaparib Trastuzumab Deruxtecan
Updated 40 times since 2020 Last updated: Mar 12, 2026 Started: May 21, 2021 Primary completion: Dec 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04585958, this PHASE1 trial focuses on Metastatic Malignant Solid Neoplasm and Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma and remains actively recruiting participants. Sponsored by National Cancer Institute (NCI), it has been updated 40 times since 2021, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~May 2022 · 3 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 – ~Feb 2023 · 3 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Jul 2023 · 4 months · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Mar 2024 · 2 months · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~May 2025 · 4 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Oct 2025 · 2 months · monthly snapshot~Oct 2025 – ~Dec 2025 · 2 months · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 6 months · monthly snapshot

Change History

40 versions recorded

  1. Mar 2026 — Present [monthly]

    Recruiting PHASE1

  2. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE1

  3. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE1

  4. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE1

    Status: Suspended → Recruiting

  5. Oct 2025 — Dec 2025 [monthly]

    Suspended PHASE1

▶ Show 35 earlier versions

  1. Aug 2025 — Oct 2025 [monthly]

    Suspended PHASE1

    Status: Recruiting → Suspended

  2. Jul 2025 — Aug 2025 [monthly]

    Recruiting PHASE1

  3. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE1

  4. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE1

    Status: Suspended → Recruiting

  5. Jan 2025 — May 2025 [monthly]

    Suspended PHASE1

  6. Sep 2024 — Jan 2025 [monthly]

    Suspended PHASE1

  7. Aug 2024 — Sep 2024 [monthly]

    Suspended PHASE1

  8. Jul 2024 — Aug 2024 [monthly]

    Suspended PHASE1

  9. Jun 2024 — Jul 2024 [monthly]

    Suspended PHASE1

  10. May 2024 — Jun 2024 [monthly]

    Suspended PHASE1

    Status: Recruiting → Suspended

  11. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE1

  12. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE1

  13. Jan 2024 — Mar 2024 [monthly]

    Recruiting PHASE1

  14. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE1

  15. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE1

  16. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1

  17. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1

  18. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1

  19. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1

  20. Mar 2023 — Jul 2023 [monthly]

    Recruiting PHASE1

  21. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE1

  22. Nov 2022 — Feb 2023 [monthly]

    Recruiting PHASE1

  23. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE1

  24. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  25. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1

  26. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1

  27. Feb 2022 — May 2022 [monthly]

    Recruiting PHASE1

  28. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1

  29. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE1

  30. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE1

  31. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  32. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  33. Jan 2021 — May 2021 [monthly]

    Not Yet Recruiting PHASE1

  34. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE1

  35. Nov 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations