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A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors

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Trial Profile

A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs DAY 301 (Primary)
  • Indications Adenocarcinoma; Cervical cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Day One Biopharmaceuticals

Most Recent Events

  • 30 Apr 2025 Trial design presented at the 116th Annual Meeting of the American Association for Cancer Research
  • 25 Feb 2025 According to a Day One Biopharmaceuticals media release, the Research and development expenses were $61.8 million and $227.7 million for the fourth quarter and full year ended December 31, 2024. The increase was primarily due to the DAY301 upfront license payment of $55.0 million in the third quarter 2024 and initiation of the DAY301 dose escalation study milestone of $20.0 million in the fourth quarter 2024.
  • 13 Jan 2025 According to a Day One Biopharmaceuticals media release, First dose cohort cleared in the Phase 1a portion of the DAY301 Phase 1a/b clinical trial.

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