Phase 1 Study of PF-08046033 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
SponsorPfizer
Started

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Record History

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  1. Minor Site details revised at 2 of 20 sites
  2. Minor Site details revised at 1 of 20 sites
  3. Minor Trial sites expanded: 15 → 20 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 11 entries
  4. Minor Site details revised at 2 of 15 sitesv5
  5. Minor Trial sites expanded: 6 → 15 locationsv4
  6. Minor Site details revised at 2 of 6 sitesv3
  7. Notable Recruitment opened
    • Trial sites expanded: 2 → 6 locations
    • Start date changed from estimate of Apr 1, 2026 to Apr 8, 2026
    • Secondary endpoints: details revised at 1 of 11 entries
    v2
  8. Minor 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.
438 trials monitored
See 32 trials at risk
4,798 trials monitored
See 270 trials at risk
1,093 trials monitored
See 62 trials at risk
and 1 more disease
This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer. The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma. The study has two parts: In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing. Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer. Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.
Trial Details
NCT Number NCT07519655
Lead Sponsor Pfizer
Conditions
(from sponsor)
Non-Small-Cell Lung, Esophageal Cancer, Cutaneous Melanoma
Related terms Esophageal Neoplasms, Lung Neoplasms, Melanoma
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov