Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Study acronym: Agni-01
StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Enrollment increased: 208 → 254 participants
    • Eligibility criteria expanded, about 91 words
    • Study description expanded, about 10 words
    • Site details revised at 8 of 10 sites
  2. Site details revised at 1 of 10 sitesv16
  3. Study sites: 9 to 10v15
  4. Primary and study completion pushed from Jun 30, 2028 to Jun 30, 2029
    • Site contacts updated at 2 of 9 sites
    • Eligibility criteria shortened, about 1 word
    v14
  5. Enrollment target: 52 to 208v13 Show 4 more changesShow less
    • Primary endpoints: 2 to 3
    • Eligibility criteria expanded, about 269 words
    • Study description expanded, about 180 words
    • Site contacts updated at 1 of 9 sites
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Oct 30, 2025 to Jun 30, 2028
    • Study completion date: Oct 30, 2027 to Jun 30, 2028
    • Site contacts updated at 1 of 9 sites
    v12
  2. Site contacts updated at 2 of 9 sitesv11
  3. Study sites: 8 to 9
    • Eligibility criteria expanded, about 11 words
    v10
  4. Study sites: 7 to 8v9
  5. Site contacts updated at 1 of 7 sitesv8
  6. Study sites: 6 to 7
    • Eligibility criteria expanded, about 45 words
    v7
  7. Study sites: 4 to 6
    • Eligibility criteria expanded, about 19 words
    v6
  8. Study sites: 2 to 4v5
  9. Enrollment target: 32 to 52v4 Show 5 more changesShow less
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study sites revised (2)
    • Study description shortened, about 2 words
    • Study title shortened, about 4 words
  10. Site details revised at 1 of 2 sitesv3
  11. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Sep 22, 2023 to Oct 25, 2023
    • Site details revised at 2 of 2 sites
    v2
  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.
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
Trial Details
NCT Number NCT06060613
Lead Sponsor Obsidian Therapeutics, Inc.
Conditions
(from sponsor)		 Tumor Skin, Metastatic Melanoma, Melanoma, Lung Cancer, Metastatic Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Melanoma, Skin Neoplasms
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov