A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 79 participants (planned 270)
    • Primary completion date changed from estimate of Sep 30, 2027 to Sep 2, 2026
    • Eligibility criteria expanded, about 41 words
    • Site details revised at 11 of 11 sites
    • Study description expanded, about 3 words
  2. Study sites: 9 to 11v6
  3. Re-verified, no change to tracked fieldsv5
  4. Site details revised at 1 of 9 sitesv4
  5. Study sites: 1 to 9
    • Secondary endpoints: details revised at 17 of 20 entries
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study description expanded, about 84 words
    v2
  7. 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.
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Trial Details
NCT Number NCT05753722
Lead Sponsor Incendia Therapeutics
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors, Non Small Cell Lung Cancer, NSCLC
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 79 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov