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A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 14 → 21 locations Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 1 of 11 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 11 entries
  2. Minor Study sites: 12 to 14v7
  3. Minor Trial sites expanded: 9 → 12 locationsv6
  4. Minor Study sites: 8 to 9v5
  5. Minor Trial sites expanded: 4 → 8 locationsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2026 to Dec 17, 2025 · Site details revised at 4 of 4 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2026 to Dec 17, 2025
    • Site details revised at 4 of 4 sites
  2. Minor Study sites: 24 to 4 Start date: Dec 2025 to Jan 2026v2 Show 1 more changeShow less
    • Start date: Dec 2025 to Jan 2026
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 main goals of this clinical trial are to find out what the best dose of the study drug, OTP-01, is for patients with solid tumors through understanding how it is tolerated and any side effects that it may cause. The trial will also see if OTP-01 causes tumors to shrink and how the body processes OTP-01 by measuring drug levels in the blood. The main questions this study aims to answer are: * What is the recommended dose of OTP-01 for adults with solid tumors? * Is OTP-01 safe and tolerable? * Does OTP-01 reduce tumor growth? Participants will: * Receive OTP-01 through an infusion into a vein. Doses will be spaced out and never more than once a week. * Have blood tests to evaluate safety and drug levels of OTP-01. These will be done often at first and then less frequently as treatment continues. * Have radiographic scans of their tumor at baseline and during the study at regular intervals. * Have the choice to have an optional tumor biopsy before and after treatment to help researchers understand how OTP-01 affects cancer and the immune system. These biopsies are voluntary and will not affect participation in the study.
Trial Details
NCT Number NCT07266428
Lead Sponsor Ottimo Pharma Limited
Conditions Advanced Solid Tumors
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov