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Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 As a Single Agent and in Combination with Pertuzumab in Subjects with HER2-Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan

Trial Profile

Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 As a Single Agent and in Combination with Pertuzumab in Subjects with HER2-Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2025

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At a glance

  • Drugs Pertuzumab (Primary) ; Trastuzumab imbotolimod (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Colorectal cancer; Endometrial cancer; Gastric cancer; HER2 positive breast cancer; Oesophageal cancer
  • Focus Therapeutic Use
  • Sponsors Bolt Biotherapeutics

Most Recent Events

  • 20 Aug 2024 Planned primary completion date changed from 1 Dec 2024 to 1 Oct 2024.
  • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology
  • 14 May 2024 According to a Bolt Biotherapeutics media release, company has decided to discontinue development of trastuzumab imbotolimod (BDC-1001) because clinical validation for the ISAC mechanism did not meet high bar for advancement.

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