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A Phase 1/2a, Open-label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEN-221 in Patients With Somatostatin Receptor 2 Expressing Advanced Cancers, Including Gastroenteropancreatic or Lung or Thymus or Other Neuroendocrine Tumors or Small Cell Lung Cancer or Large Cell Neuroendocrine Carcinoma of the Lung

Trial Profile

A Phase 1/2a, Open-label Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEN-221 in Patients With Somatostatin Receptor 2 Expressing Advanced Cancers, Including Gastroenteropancreatic or Lung or Thymus or Other Neuroendocrine Tumors or Small Cell Lung Cancer or Large Cell Neuroendocrine Carcinoma of the Lung

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 16 Dec 2021

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At a glance

  • Drugs Nendratareotide uzatansine (Primary)
  • Indications Gastrointestinal cancer; Lung cancer; Malignant thymoma; Merkel cell carcinoma; Neuroendocrine carcinoma; Neuroendocrine tumours; Pancreatic cancer; Paraganglioma; Phaeochromocytoma; Small cell lung cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Tarveda Therapeutics
  • Most Recent Events

    • 16 Nov 2021 Primary endpoints have been added (MTD, RP2D, DLTs, DOR, CBR, OR). Number of treatment arms have been increased from 1 to 4.
    • 01 Nov 2021 According to a Tarveda Therapeutics media release, data will be presented at the North American Neuroendocrine Tumor Society (NANETS) 2021 Multidisciplinary NET Medical Virtual Symposium.
    • 08 Jun 2021 Results (data cut off: July 31, 2020; n=32) assessing the efficacy outcomes for patients enrolled in the GI mid-gut cohort and the safety data for the entire study presented at the 57th Annual Meeting of the American Society of Clinical Oncology
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