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A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors

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Trial Profile

A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2025

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At a glance

  • Drugs Caxmotabart Entudotin (Primary)
  • Indications Advanced breast cancer; Gallbladder cancer; Gastric cancer; HER2 positive breast cancer; Oesophageal cancer; Ovarian cancer; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Iksuda Therapeutics

Most Recent Events

  • 01 Jul 2025 According to LigaChemBio media release, the company presented the initial results from the IKS014 from this trial at LigaChemBio Global R&D Day 2025.
  • 01 Jul 2025 According to LigaChemBio media release, the upcoming dose-expansion part of this trial will be extended to include new sites in the United States and Singapore.
  • 01 Jul 2025 According to an Iksuda Therapeutics media release, the first stage of this trial, which is to determine the recommended phase 2 dose for dose expansion, is nearing completion. The USFDA has cleared IND application for IKS014 allowing Iksuda to access patients across sites in the United States, alongside sites in Australia and New Zealand, and Singapore. The phase 1 trial is expected to complete in 2H 2026.

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