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A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients with Advanced Solid TuMORs, in CombiNation with a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination with ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)

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Trial Profile

A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients with Advanced Solid TuMORs, in CombiNation with a Checkpoint INhibitor TreatinG Wild-type Non-Small Cell Lung Cancer, or in Combination with ChemoTherapy for Metastatic or Advanced PAncreatic Ductal AdenocaRcinoma (MORNINGSTAR)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Feb 2025

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At a glance

  • Drugs Programmed cell death 1 receptor antagonists (Primary) ; PT 199 (Primary)
  • Indications Adenocarcinoma; Non-small cell lung cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Acronyms MORNINGSTAR
  • Sponsors Phanes Therapeutics

    • Most Recent Events

    • 08 Jan 2025 The protocol has been amended.
    • 08 Jan 2025 Planned End Date changed from 31 Aug 2028 to 1 Aug 2028.
    • 07 Jan 2025 Phase has been changed phase I\II.Intevention model has been changed with the addition of ICI Combination Dose Expansion in NSCLC (Part C), and Combination with Chemotherapy in frontline (1L) PDAC patients (Part D).No.Of arms increased to 4.

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