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A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors

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Trial Profile

A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Aug 2023

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At a glance

  • Drugs GQ 1001 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Biliary cancer; Gastric cancer; HER2 positive breast cancer; Oesophageal cancer; Salivary gland cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Conjugate Light; Suzhou GeneQuantum Healthcare

Most Recent Events

  • 19 Apr 2023 Initial results (As of Dec 28,2022, n=32) assessing the safety, tolerability, pharmacokinetics and antitumor activity of GQ1001 in subjects with HER2+ advanced solid tumors presented at the 114th Annual Meeting of the American Association for Cancer Research
  • 20 Mar 2023 Planned primary completion date changed from 1 Dec 2022 to 1 Mar 2024.
  • 28 Sep 2022 Planned number of patients changed from 27 to 96.

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