deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 5-arm NCT05706129

A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

A Multicenter, Open-Label, Non-Randomized Phase 1/2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors

Sponsor: ITM Oncologics GmbH

Conditions Clear Cell Renal Cell Cancer (ccRCC) Colorectal Cancer (CRC) Head and Neck Cancer (H&N) Indeterminate Renal Mass (IDRM) Muscle Invasive Bladder Cancer (MIBC) Pancreatic Ductal Adenocarcinoma (PDAC) Squamous Non-Small Cell Lung Cancer (NSCLC) Triple Negative Breast Cancer (TNBC) Urothelial Carcinoma (UC)
Interventions [177Lu]Lu-DPI-4452 [68Ga]Ga-DPI-4452
Updated 23 times since 2023 Last updated: Oct 16, 2025 Started: Mar 14, 2023 Primary completion: Jun 30, 2027 Completion: Mar 31, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Clear Cell Renal Cell Cancer (ccRCC) and Colorectal Cancer (CRC) and is currently actively recruiting participants. ITM Oncologics GmbH leads this study, which shows 23 recorded versions since 2023 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 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 – ~Jan 2024 · 4 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · 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 – ~May 2025 · 4 months · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – present · 9 months · monthly snapshot

Change History

23 versions recorded

  1. Nov 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Sep 2025 — Nov 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jul 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 18 earlier versions

  1. Jan 2025 — May 2025 [monthly]

    Recruiting PHASE1/PHASE2

  2. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE1/PHASE2

  4. Oct 2024 — Nov 2024 [monthly]

    Recruiting PHASE1/PHASE2

  5. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE1/PHASE2

  6. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

  7. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  8. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  9. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE1_PHASE2

  10. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE1_PHASE2

  12. Sep 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  13. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  14. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1_PHASE2

  15. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

  16. Apr 2023 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

  17. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  18. Feb 2023 — Mar 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • ITM Oncologics GmbH
Data source: ITM Oncologics GmbH

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

Study Locations