deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT03316638

A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors (Ulysse)

Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients with Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study

Sponsor: Pierre Fabre Medicament

Conditions Advanced or Metastatic Solid Tumors
Interventions W0101 - Cohort A1 W0101 - Cohort A2 W0101 - Expansion Phase
Updated 11 times since 2017 Last updated: Dec 5, 2024 Started: Nov 24, 2017 Primary completion: Oct 30, 2021 Completion: Jul 5, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

delay in participants recruitment in cohort A3 and IMP manufacturing issues

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This PHASE1/PHASE2 trial investigates Advanced or Metastatic Solid Tumors and is currently terminated or withdrawn. Pierre Fabre Medicament leads this study, which shows 11 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

~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshotNot Yet Recruiting~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshotRecruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotRecruiting~Mar 2019 – ~May 2020 · 14 months · monthly snapshotRecruiting~May 2020 – ~Jan 2021 · 8 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Jan 2023 · 16 months · monthly snapshotRecruiting~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshotActive Not Recruiting~Jan 2025 – present · 17 months · monthly snapshotTerminated

Change History

11 versions recorded

  1. Jan 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not Recruiting → Terminated

  2. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Sep 2021 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

▶ Show 6 earlier versions

  1. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  2. May 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  3. Mar 2019 — May 2020 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jun 2018 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  5. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  6. Nov 2017 — Dec 2017 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pierre Fabre Medicament
Data source: Pierre Fabre Medicament

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

Study Locations