ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients with HER2-Positive Tumors

• Research type

  Research Study

• Full title

  A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients with HER2-Positive Advanced Solid Tumors

• IRAS ID

  1009172

• Contact name

  Ding Zhou

• Contact email

  ding.zhou@zionpharma.com

• Sponsor organisation

  Roche Products Ltd

• Clinicaltrials.gov Identifier

  NCT05593094

• Research summary

  The purpose of this study to test how safe a new drug called ZN-A-1041 is. This study is a first in human, open-label study. This means the study is our first assessment of how safe the drug is for people with human epidermal growth factor receptor 2 (HER2)- positive advanced solid tumours (this is known as a Phase 1 study).
  The main purpose of this study is to evaluate the safety (side effects and laboratory values) and tolerability (how well participants tolerate the side effects) of the ZN-A-1041 when given as single, and multiple doses taken orally (by mouth) alone or in combination with these other approved drugs: fam-trastuzumab deruxtecan (Enhertu, given as an infusion into the vein) or pertuzumab, trastuzumab, and hyaluronidase (PHESGO, given as an injection into the thigh). In addition, this study will also assess the pharmacokinetics, or “PK” of the study drugs (which means how the body absorbs them, how them goes throughout the body, and how the body metabolizes and eliminates them) and efficacy (which means what effects a study drug has on the body) of the study drugs.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  24/NW/0034

• Date of REC Opinion

  13 Apr 2024

• REC opinion

  Further Information Favourable Opinion