deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 1-arm NCT04535401

Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines

Phase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination With FOLFIRI in GI Malignancies With a Focus on Metastatic Colorectal and Gastric/Gastroesophageal Cancers

Sponsor: National Cancer Institute (NCI)

Conditions Advanced Colorectal Carcinoma Advanced Digestive System Carcinoma Advanced Gastric Carcinoma Advanced Gastroesophageal Junction Adenocarcinoma Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Metastatic Colorectal Carcinoma Metastatic Digestive System Carcinoma Metastatic Gastric Carcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Stage III Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8
Interventions Biopsy Biospecimen Collection Diagnostic Imaging Elimusertib Fluorouracil Irinotecan Hydrochloride Leucovorin Calcium
Updated 30 times since 2020 Last updated: Oct 9, 2024 Started: Aug 13, 2021 Primary completion: Mar 29, 2024 Completion: Apr 29, 2025
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 Advanced Colorectal Carcinoma and Advanced Digestive System Carcinoma, this trial is ongoing. The trial is conducted by National Cancer Institute (NCI) and has accumulated 30 data snapshots since 2021. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~May 2022 · 2 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 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Jun 2023 · 3 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · 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 – ~Dec 2023 · 2 months · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~May 2024 · 4 months · 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 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Sep 2025 · 10 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

30 versions recorded

  1. Sep 2025 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Nov 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1

  3. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 25 earlier versions

  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  2. May 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Jan 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Dec 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Oct 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

  6. Sep 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  7. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1

  8. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1

  9. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1

  10. Mar 2023 — Jun 2023 [monthly]

    Recruiting PHASE1

  11. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE1

  12. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE1

  13. Sep 2022 — Jan 2023 [monthly]

    Recruiting PHASE1

  14. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1

  15. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1

  16. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1

  17. Mar 2022 — May 2022 [monthly]

    Recruiting PHASE1

  18. Dec 2021 — Mar 2022 [monthly]

    Recruiting PHASE1

  19. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE1

  20. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  21. Apr 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE1

  22. Mar 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE1

  23. Feb 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE1

  24. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE1

  25. Oct 2020 — Jan 2021 [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