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Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)

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Trial Profile

Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 May 2025

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At a glance

  • Drugs Docetaxel (Primary) ; Gotistobart (Primary) ; Pembrolizumab
  • Indications Adenoid cystic carcinoma; Advanced breast cancer; Carcinoma; Colorectal cancer; Gastric cancer; Head and neck cancer; Liver cancer; Male breast cancer; Malignant melanoma; Merkel cell carcinoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Renal cell carcinoma; Sarcoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Acronyms PRESERVE-001
  • Sponsors OncoC4; OncoImmune

Most Recent Events

  • 27 May 2025 According to a BioNTech media release, data from this study will be presented at the 2025 ASCO Annual Meeting.
  • 23 May 2025 Status changed from recruiting to active, no longer recruiting.
  • 09 May 2024 Planned End Date changed from 31 Dec 2024 to 31 Dec 2027.

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