AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 4 entries Show 4 more changesShow less
    • Trial sites expanded: 19 → 27 locations
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 17 entries
    • Collaborators expanded, about 2 words
  2. Site details revised at 1 of 19 sitesv10
  3. Study sites: 18 to 19v9
  4. Enrollment increased: 430 → 480 participants
    • Study sites: 16 to 18
    v8
  5. Study sites: 11 to 16
    • Study title expanded, about 1 word
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 10 to 11v6
  2. Study sites: 9 to 10v5
  3. Study sites: 8 to 9v4
  4. Study sites: 4 to 8
    • Eligibility criteria expanded, about 1 word
    v3
  5. Start date changed from estimate of Jun 19, 2025 to Jun 4, 2025v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Avenzo Therapeutics, Inc.
4 trials monitored
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Lung Cancer
4,798 trials monitored
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Head & Neck Cancer
2,608 trials monitored
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Bladder Cancer
1,058 trials monitored
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and 2 more diseases
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.
Trial Details
NCT Number NCT07038343
Lead Sponsor Avenzo Therapeutics, Inc.
Collaborators: DualityBio Inc.
Conditions
(from sponsor)		 Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers, Epithelial Tumor, Biliary Tract Cancer (BTC), Urothelial Cancer, Nasopharyngeal Cancers
Related terms Biliary Tract Neoplasms, Carcinoma, Lung Neoplasms, Nasopharyngeal Neoplasms, Neoplasm Metastasis, Small Cell Lung Carcinoma
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov