A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Oct 31, 2025 → Mar 29, 2027
See other at-risk trials from TORL Biotherapeutics, LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 31, 2025 to Mar 29, 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Oct 31, 2026 to May 31, 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 20 entries
    • Site details revised at 10 of 10 sites
  2. Study sites: 5 to 10v9
  3. Study sites: 3 to 5
    • Secondary endpoints revised (20)
    v8
  4. Study sites: 1 to 3v7
  5. Study title expanded, about 3 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2023 to Dec 4, 2023
    • Site details revised
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Start date: Oct 31, 2023 to Dec 31, 2023v3
  4. Re-verified, no change to tracked fieldsv2
  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 first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).
Trial Details
NCT Number NCT06005740
Lead Sponsor TORL Biotherapeutics, LLC
Collaborators: Translational Research in Oncology
Conditions
(from sponsor)		 Advanced Solid Tumor, Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov