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Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

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Trial Profile

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 02 Mar 2026

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At a glance

  • Drugs Gallium-68 NNS309 (Primary) ; Lutetium-177 NNS309 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Colorectal cancer; HER2 negative breast cancer; Non-small cell lung cancer; Pancreatic ductal carcinoma; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 11 Dec 2025 Planned number of patients changed from 124 to 162.
  • 11 Dec 2025 Planned End Date changed from 26 Jun 2030 to 16 Jan 2031.
  • 11 Dec 2025 Planned primary completion date changed from 25 Jun 2030 to 15 Jan 2031.

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