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A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

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Trial Profile

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Jun 2025

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At a glance

  • Drugs ARTS 021 (Primary) ; Carboplatin (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary) ; Palbociclib (Primary) ; Sacituzumab govitecan (Primary) ; Abemaciclib; Ribociclib
  • Indications Advanced breast cancer; Endometrial cancer; Gastric cancer; HER2 negative breast cancer; HER2 positive breast cancer; Lung cancer; Male breast cancer; Oesophageal cancer; Ovarian cancer; Solid tumours; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Allorion Therapeutics; Avenzo Therapeutics

Most Recent Events

  • 17 Sep 2024 Trial design presented at the 49th European Society for Medical Oncology Congress.
  • 03 Sep 2024 According to Avenzo Therapeutics media release, company announced that it has entered into a clinical study collaboration with Gilead Sciences, to evaluate the safety and efficacy of AVZO-021, in combination with Gileads Trodelvy (sacituzumab govitecan-hziy), for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. company is looking forward to initiate combination cohorts with Trodelvy, in the Phase 1b portion of this trial.
  • 24 Oct 2023 Trial design presented at the 48th European Society for Medical Oncology Congress

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