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ARX 788

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Drug Profile

ARX 788

Alternative Names: Antibody-drug conjugate - Ambrx/Zhejiang Medicine; ARX-788; JNJ-0683; NCB-001

Latest Information Update: 26 Feb 2026

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At a glance

  • Originator Ambrx
  • Developer Ambrx; NovoCodex Biopharmaceuticals
  • Class Antineoplastics; Drug conjugates; Immunoconjugates; Immunotoxins; Monoclonal antibodies; Small molecules
  • Mechanism of Action Tubulin inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Gastric cancer
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II/III HER2 positive breast cancer
  • Suspended Breast cancer; Gastric cancer; Solid tumours

Most Recent Events

  • 13 Feb 2026 Ambrx plans a phase II trial for Breast cancer (Late-stage disease, Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable) in USA (IV), in March 2026 (NCT06224673)
  • 09 Dec 2025 Adverse events and efficacy data from a phase-II trial in HER2-positive breast cancer presented at the 48th Annual San Antonio Breast Cancer Symposium (SABCS-2025)
  • 17 Oct 2025 Efficacy and adverse events data from the phase II ACE-Breast-06 trial in Her2 positive Breast cancer presented at the 50th European Society for Medical Oncology Congress (ESMO-2025)

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