deltatrials
Recruiting PHASE1 INTERVENTIONAL 3-arm NCT06364410

Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors

Phase 1 Study of Trastuzumab Deruxtecan (DS-8201a) in Combination With Azenosertib (ZN-c3) in HER2-Expressing/Amplified Cyclin E-Amplified Gastric/Gastroesophageal Junction Cancer and Other Solid Tumors With HER2 Expression

Sponsor: National Cancer Institute (NCI)

Conditions 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 Locally Advanced Gastric Carcinoma Locally Advanced Gastroesophageal Junction Adenocarcinoma Locally Advanced Malignant Solid Neoplasm Metastatic Gastric Carcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Malignant Solid Neoplasm Unresectable Gastric Carcinoma Unresectable Gastroesophageal Junction Adenocarcinoma Unresectable Malignant Solid Neoplasm
Interventions Azenosertib Biopsy Procedure Biospecimen Collection Computed Tomography Echocardiography Test Magnetic Resonance Imaging Multigated Acquisition Scan Trastuzumab Deruxtecan
Updated 13 times since 2024 Last updated: Mar 12, 2026 Started: Feb 3, 2025 Primary completion: Jul 8, 2027 Completion: Jul 8, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Clinical Stage III Gastric Cancer AJCC v8 and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and is currently actively recruiting participants. National Cancer Institute (NCI) leads this study, which shows 13 recorded versions since 2025 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Apr 2025 · 59 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Oct 2025 · 5 months · monthly snapshotRecruiting~Oct 2025 – ~Feb 2026 · 4 months · monthly snapshotRecruiting~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 6 months · monthly snapshotRecruiting

Change History

13 versions recorded

  1. Mar 2026 — Present [monthly]

    Recruiting PHASE1

    Status: Suspended → Recruiting

  2. Feb 2026 — Mar 2026 [monthly]

    Suspended PHASE1

    Status: Recruiting → Suspended

  3. Oct 2025 — Feb 2026 [monthly]

    Recruiting PHASE1

  4. May 2025 — Oct 2025 [monthly]

    Recruiting PHASE1

  5. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE1

▶ Show 8 earlier versions

  1. Feb 2025 — Apr 2025 [monthly]

    Recruiting PHASE1

  2. Jan 2025 — Feb 2025 [monthly]

    Recruiting PHASE1

  3. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1

  4. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  5. Oct 2024 — Nov 2024 [monthly]

    Not Yet Recruiting PHASE1

  6. Sep 2024 — Oct 2024 [monthly]

    Not Yet Recruiting PHASE1

  7. Jul 2024 — Sep 2024 [monthly]

    Not Yet Recruiting PHASE1

  8. May 2024 — Jul 2024 [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