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A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

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Trial Profile

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Saruparib (Primary) ; Carboplatin; Paclitaxel; Trastuzumab-deruxtecan
  • Indications Advanced breast cancer; Biliary cancer; Bladder cancer; Cervical cancer; Colorectal cancer; Endometrial cancer; Gastric cancer; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Acronyms PETRA
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 19 Sep 2024 Planned End Date changed from 15 Dec 2026 to 3 Mar 2027.
    • 19 Sep 2024 Planned primary completion date changed from 15 Dec 2026 to 3 Mar 2027.
    • 10 Apr 2024 Results (n=203, cut off date June 2, 2023) assessing efficacy and safety of Saruparib, presented at the 115th Annual Meeting of the American Association for Cancer Research.

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