deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT03364348

4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer

A Phase 1B Dose Escalation Trial of Human Anti 4 1BB Agonistic Antibody Utomilumab (PF 05082566) in Combination With Ado Trastuzumab Emtansine or Trastuzumab in Patients With HER2 Postive Advanced Breast Cancer

Sponsor: George W. Sledge Jr.

Conditions HER2 Positive Breast Carcinoma Recurrent Breast Carcinoma Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Interventions Ado-Trastuzumab Emtansine Trastuzumab Utomilumab
Updated 11 times since 2017 Last updated: Sep 22, 2022 Started: Oct 30, 2017 Primary completion: Feb 15, 2021 Completion: Feb 14, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on HER2 Positive Breast Carcinoma and Recurrent Breast Carcinoma, this trial is completed. The trial is conducted by George W. Sledge Jr. and has accumulated 11 data snapshots since 2017. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshotNot Yet Recruiting~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotRecruiting~Jun 2018 – ~Apr 2020 · 22 months · monthly snapshotRecruiting~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshotRecruiting~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotRecruiting~Feb 2021 – ~Nov 2022 · 21 months · monthly snapshotActive Not Recruiting~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

11 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

  5. Nov 2022 — Dec 2022 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

▶ Show 6 earlier versions

  1. Feb 2021 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  2. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1

  3. Apr 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  4. Jun 2018 — Apr 2020 [monthly]

    Recruiting PHASE1

  5. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  6. Dec 2017 — Feb 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Oct 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • George W. Sledge Jr.
  • National Cancer Institute (NCI)
Data source: Stanford University

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

Study Locations