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A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors First-in-human clinical trial of ALE-P03

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Trial Profile

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors First-in-human clinical trial of ALE-P03

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Sep 2025

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At a glance

  • Drugs ALE P03 (Primary)
  • Indications Cervical cancer; Cholangiocarcinoma; Colorectal cancer; Non-small cell lung cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Alentis Therapeutics

Most Recent Events

  • 12 Sep 2025 Status changed from planning to recruiting.
  • 12 Nov 2024 According to an Alentis Therapeutics media release, the $181.4 million Series D financing supporting this trial, was led by OrbiMed with co-leads Novo Holdings and Jeito Capital and strengthened by substantial contributions from Frazier Life Sciences, Longitude Capital, RA Capital, and Catalio Capital, among others.
  • 12 Nov 2024 According to an Alentis Therapeutics media release, company has co-led a $181.4 million Series D financing in Alentis Therapeutics. This financing will enable Alentis to begin Phase 1/2 trials for two first-in-class ADCs: ALE.P02, which targets advanced or metastatic CLDN1+ squamous solid tumours with a tubulin inhibitor payload, and ALE.P03, which targets CLDN1+ tumours with a distinct topoisomerase I inhibitor payload.

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