A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 28, 2028 → Oct 28, 2029
See other at-risk trials from Antares Therapeutics, Inc

Record History

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  1. Primary completion pushed from Oct 28, 2028 to Oct 28, 2029 Show 6 more changesShow less
    • Recruitment opened
    • Primary endpoints: details revised at 2 of 10 entries
    • Trial sites expanded: 0 → 6 locations
    • Start date changed from estimate of Aug 1, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 4 of 24 entries
  2. 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.
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors. This study consists of 2 parts. Part 1 evaluates ATX-898 as monotherapy and Part 2 evaluates ATX-898 in combination with anti-neoplastic agents of interest. Both parts will consists of a dose escalation portion and a dose expansion portion.
Trial Details
NCT Number NCT07767474
Lead Sponsor Antares Therapeutics, Inc
Conditions
(from sponsor)		 Advanced Solid Tumors
Related terms Breast Neoplasms
Enrollment 343 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov