CERTIS1

• Research type

  Research Study

• Full title

  A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1)

• IRAS ID

  1005683

• Contact name

  Fabrice Marsicano

• Contact email

  Fabrice.Marsicano@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-006227-17

• Clinicaltrials.gov Identifier

  NCT05417594

• Research summary

  This is a first time in human study primarily designed to evaluate the safety and tolerability of AZD9574 as monotherapy and in combination with anti-cancer agents at increasing dose levels in patients with advanced solid malignancies.
  AZD9574 is a type of drug known as a PARP inhibitor (PARPi). PARP inhibitors are a type of targeted cancer drugs.
  There are now global regulatory approvals for PARPi in over 50 countries for ovarian, fallopian tube, primary peritoneal, breast, prostate, or pancreatic cancers, including olaparib (Lynparza®), rucaparib (Rubraca®), niraparib (Zejula®), and talazoparib (TALZENNA®).
  The hypothesis is that AZD9574 will offer a more efficacious and less toxic cancer treatment compared with currently approved PARPi and may provide a new treatment option for patients with central nervous system (CNS) malignancies and brain metastases due to the unique property of AZD9574 to readily cross the blood brain barrier.
  The study will be conducted in different modules. Module 1 will look at AZD9574 taken alone, and Module 2 will look at AZD9574 taken in combination with temozolomide. More modules may be added during the study.
  Module 1 will include Part A and Part B.
  Part A will involve testing increasing doses of AZD9574 until a dose and schedule is identified which is safe and tolerated and can be recommended for Part B of this study.
  Part B will further evaluate the safety, tolerability and efficacy of AZD9574.
  About 255 people will take part in this study overall, up to 180 of those people will take part in Module 1 and up to 75 of those people will take part in Module 2. Part A of Module 1 will require up to 45 participants, and up to an additional 45 patients as back-fill cohorts. For Part B, approximately 90 participants are planned.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  22/LO/0510

• Date of REC Opinion

  18 Oct 2022

• REC opinion

  Further Information Favourable Opinion