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A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors

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Trial Profile

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1305 in Subjects with Advanced/Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 May 2025

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At a glance

  • Drugs BNT 325 (Primary) ; Pembrolizumab (Primary) ; PM-8002 (Primary)
  • Indications Advanced breast cancer; Cervical cancer; Colorectal cancer; Fallopian tube cancer; HER2 negative breast cancer; Mesothelioma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Small cell lung cancer; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Duality Biologics

Most Recent Events

  • 05 May 2025 According to the BioNTech media release, preliminary data from this study presented at the Society of Gynecologic Oncology (SGO) Annual Meeting, March, 2025.
  • 05 May 2025 According to the BioNTech media release, Interim data from this study presented at the American Association for Cancer Research (AACR), April, 2025.
  • 30 Apr 2025 Results assessing an activity BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors were presented at the 116th Annual Meeting of the American Association for Cancer Research.

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