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A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

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Trial Profile

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

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

Latest Information Update: 26 May 2025

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At a glance

  • Drugs Imifoplatin (Primary)
  • Indications Adenocarcinoma; Malignant thymoma; Prostate cancer; Solid tumours; Thymoma
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Promontory Therapeutics

Most Recent Events

  • 20 May 2025 According to a Promontory Therapeutics media release, company announced a successful in-person End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA), allowing the company to prepare and submit a registrational Phase 3 study of PT-112 monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC).
  • 20 May 2025 According to a Promontory Therapeutics media release, preliminary clinical outcomes will be presented on June 2nd at the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting.
  • 20 May 2025 According to a Promontory Therapeutics media release, Immune response biomarker data were recently presented at the American Association of Cancer Research (AACR) 2025 Annual Meeting.

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