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A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Notable Primary endpoints: details revised at 2 of 5 entries
    • Study sites: 3 to 4
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 6 of 20 entries
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-6723. The investigational drug ARV-6723 will be given as an oral tablet on its own and also in combination with other drugs. Researchers think that ARV-6723 can help the body's immune system to better recognize, attack, and destroy cancer cells in adults with advanced solid tumors. ARV-6723 is an investigational drug, and this is the first time ARV-6723 will be used in humans. Depending on the treatment assignment, the investigational drug, ARV-6723, will be given as an oral tablet either on its own (monotherapy) or in combination with pembrolizumab, either through a vein (intravenously or IV) or through an injection beneath the skin (subcutaneously or SQ). This study will include multiple parts: In Part A1 (Phase 1a), different small groups of participants will receive lower to higher doses of ARV-6723 as monotherapy or in combination with standard-dose of pembrolizumab. In Part A2 (Phase 1b), two groups of participants with specific tumor indication(s) (TBD) will receive one of two doses selected based on information from Part A1. Details of Part B will be determined based on information generated from Part A.
Trial Details
NCT Number NCT07749586
Lead Sponsor Arvinas Inc.
Conditions
(from sponsor)
Advanced Solid Tumor
Related terms Carcinoma, Hepatocellular, Carcinoma, Merkel Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Esophageal Neoplasms, Hereditary Sensory and Autonomic Neuropathies, Melanoma, Nasopharyngeal Carcinoma, Ovarian Neoplasms, Small Cell Lung Carcinoma, Stomach Neoplasms, Triple Negative Breast Neoplasms, Uterine Cervical Neoplasms
Enrollment 499 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov