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A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

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Trial Profile

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Nov 2024

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At a glance

  • Drugs Aldesleukin (Primary) ; AU-007 (Primary)
  • Indications Bladder cancer; Cancer; Colorectal cancer; Head and neck cancer; Malignant melanoma; Merkel cell carcinoma; Nasopharyngeal cancer; Non-small cell lung cancer; Renal cell carcinoma; Solid tumours; Urogenital cancer
  • Focus Adverse reactions; First in man
  • Sponsors Aulos Bioscience

    • Most Recent Events

    • 27 Nov 2024 According to an Aulos Bioscience media release, company announced dosing of the first patient with AU-007, avelumab, a PD-L1 antibody with Fc effector function, and Sc aldesleukin in a Phase 2 cohort focused on the second-line treatment of PD-L1+ (NSCLC). Aulos announced a collaboration and supply agreement with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany for use of avelumab in combination with AU-007 and SC aldesleukin in an additional Phase 2 cohort of this trial.
    • 27 Nov 2024 According to an Aulos Bioscience media release, company plans to share preliminary data from the Phase 2 cohort studying AU-007 with avelumab and low-dose, subcutaneous aldesleukin as a second-line treatment for PD-L1+ NSCLC in the first half of 2025.
    • 25 Oct 2024 Results determining the phase 2 dose of AU-007 were presented at the 36th EORTC-NCI-AACR Symposium on molecular targets and cancer therapeutics.

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