deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT03214250

Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Sponsor: Apexigen America, Inc.

Conditions Metastatic Pancreatic Adenocarcinoma
Interventions APX005M Gemcitabine Nab-Paclitaxel Nivolumab
Updated 19 times since 2017 Last updated: Dec 21, 2022 Started: Jul 21, 2017 Primary completion: Feb 11, 2021 Completion: Feb 25, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03214250, this PHASE1/PHASE2 trial focuses on Metastatic Pancreatic Adenocarcinoma and remains completed. Sponsored by Apexigen America, Inc., it has been updated 19 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Aug 2017 – ~Nov 2017 · 3 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Jan 2019 · 4 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Jul 2019 · 4 months · monthly snapshot~Jul 2019 – ~Sep 2020 · 14 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Sep 2022 · 8 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Jan 2023 · 2 months · monthly snapshot~Jan 2023 – ~Jun 2023 · 5 months · monthly snapshot~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

19 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Jun 2023 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jan 2023 — Jun 2023 [monthly]

    Completed PHASE1_PHASE2

  5. Nov 2022 — Jan 2023 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 14 earlier versions

  1. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Jan 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Nov 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Sep 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  7. Jul 2019 — Sep 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  8. Mar 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  9. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  10. Sep 2018 — Jan 2019 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  12. Dec 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  13. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE1_PHASE2

  14. Aug 2017 — Nov 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Jul 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Apexigen America, Inc.
  • Bristol-Myers Squibb
  • Cancer Research Institute, New York City
  • Parker Institute for Cancer Immunotherapy
Data source: Parker Institute for Cancer Immunotherapy

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

Study Locations