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A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
SponsorPfizer
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 4 → 5 primary endpoints
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Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Notable Primary endpoint(s) modified Show 5 more changesShow less
    • Interventions modified
    • Trial arms changed: 3 → 8
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised at 6 of 31 sites
  3. Notable Enrollment increased: 310 → 540 participants
    • Study sites: 30 to 31
    v8
  4. Minor Study sites: 28 to 30v7
  5. Minor Site details revised at 3 of 28 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 13 to 28v5
  2. Minor Study sites: 2 to 13v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Aug 19, 2028 to Jul 8, 2028
    • Study completion date: Aug 19, 2029 to Jul 8, 2029
    • Start date changed from estimate of Aug 7, 2025 to Aug 20, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
436 trials monitored
See 32 trials at risk
4,790 trials monitored
See 263 trials at risk
and 3 more diseases
The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.
Trial Details
NCT Number NCT07090499
Lead Sponsor Pfizer
Conditions
(from sponsor)
Advanced/Metastatic Solid Tumors, Bladder Cancer, Urothelial Carcinoma, Advanced Non-Small Cell Lung Cancer, Carcinoma, Non Small Cell Lung, Carcinoma, Squamous Cell of Head and Neck, Head and Neck Cancer, Esophageal Cancer +5 more
Related terms Adenocarcinoma Of Esophagus, Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Head and Neck Neoplasms, Pancreatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Urinary Bladder Neoplasms
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov