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Clinical Trial Summary

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.


Clinical Trial Description

Phase 1a will employ an adaptive model guided with overdose control principle to make dose recommendations and estimate the maximum tolerated dose (MTD) of PEN-866 (single agent). Phase 1b will employ a standard 3 + 3 design to make dose recommendations and estimate the MTD of PEN-866 in combination therapy. Phase 2a (single agent) will assess the safety, tolerability, pharmacokinetic, and pharmacodynamics profile of PEN-866 (single agent) at the recommended Phase 2 dose determined at the conclusion of Phase 1a in patients with advanced solid malignancies. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma of the Pancreas
  • Advanced Cancer
  • Anus Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Endometrial Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Neoplasms
  • Pancreatic Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer
  • Solid Carcinoma
  • Solid Tumor
  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Anus
  • Squamous Cell Carcinoma of the Cervix
  • Squamous Cell Carcinoma of the Penis
  • Squamous Cell Carcinoma of the Vulva
  • Vulvar Neoplasms

NCT number NCT03221400
Study type Interventional
Source Tarveda Therapeutics
Contact Tarveda Clinical Information Center
Phone (617) 923-4100
Email clinical.information@tarvedatx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 29, 2017
Completion date June 2023

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