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A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors

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Trial Profile

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs XTX 301 (Primary)
  • Indications Advanced breast cancer; Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Head and neck cancer; Lymphoma; Malignant melanoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Prostate cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Xilio Therapeutics

Most Recent Events

  • 07 Nov 2025 According to Xilio Therapeutics media release, In the third quarter of 2025, Xilio initiated dosing in the Phase 2 portion of the clinical trial evaluating efarindodekin alfa as a monotherapy in patients with certain advanced solid tumors.
  • 07 Nov 2025 According to Xilio Therapeutics media release, Xilio has completed enrollment in the Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion portions of the ongoing Phase 1/2 clinical trial, and evaluation of those patients is ongoing.
  • 07 Nov 2025 According to Xilio Therapeutics media release, data from the trial were presented at at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 5-9, 2025, in National Harbor, Maryland.

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