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First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

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Trial Profile

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 16 Feb 2026

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At a glance

  • Drugs Acasunlimab (Primary) ; Pembrolizumab (Primary)
  • Indications Advanced breast cancer; Carcinoma; Cervical cancer; Endometrial cancer; Head and neck cancer; Non-small cell lung cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Genmab

Most Recent Events

  • 29 Dec 2025 Status changed from active, no longer recruiting to discontinued, according to Genmab media release. This decision reflects prioritization of higher impact opportunities across Genmabs late stage pipeline and increasingly competitive landscape.
  • 29 Oct 2024 Planned End Date changed from 1 Oct 2025 to 1 Feb 2026.
  • 29 Oct 2024 Planned primary completion date changed from 1 Jan 2025 to 1 Feb 2026.

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