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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-1303/BNT323 in Patients 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-1303/BNT323 in Patients with Advanced/Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 07 Oct 2024

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At a glance

  • Drugs BNT 323 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Brain metastases; Carcinoma; Colorectal cancer; Endometrial cancer; Gastric cancer; HER2 negative breast cancer; HER2 positive breast cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Duality Biologics

    • Most Recent Events

    • 08 Aug 2024 Planned End Date changed from 1 Oct 2025 to 1 Oct 2027.
    • 08 Aug 2024 Planned primary completion date changed from 1 Jun 2025 to 1 Apr 2026.
    • 05 Aug 2024 According to a BioNTech media release, endometrial carcinoma cohort has completed enrollment and data from this cohort are expected in 2025.

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