deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT02838823

Safety and Tolerability of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Patients With Advanced Breast Cancer

A Phase I,Open,Mono-center and Dose Escalation Study Investigating Tolerance and Pharmacokinetics of Single and Multiple Doses of Anti-PD-1 Monoclonal Antibody in Patients With Triple-negative Breast Cancer

Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Conditions Breast Cancer
Updated 10 times since 2017 Last updated: Oct 22, 2019 Started: Jul 31, 2016 Primary completion: Dec 31, 2018 Completion: Sep 30, 2019
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 Breast Cancer, this trial is completed. The trial is conducted by Shanghai Junshi Bioscience Co., Ltd. and has accumulated 10 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotRecruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotActive Not Recruiting~Jul 2018 – ~Feb 2019 · 7 months · monthly snapshotActive Not Recruiting~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshotActive Not Recruiting~Apr 2019 – ~Nov 2019 · 7 months · monthly snapshotActive Not Recruiting~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Nov 2019 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  5. Apr 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE1

Show 5 earlier versions
  1. Feb 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE1

  2. Jul 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE1

  3. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1

  4. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  5. Jan 2017 — Apr 2018 [monthly]

    Recruiting PHASE1

    First recorded

Jul 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shanghai Junshi Bioscience Co., Ltd.
Data source: Shanghai Junshi Bioscience Co., Ltd.

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

Study Locations