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Trial Summary


Protocol No.CTO-PT112-101
StatusOPEN TO ACCRUAL
Principal InvestigatorAdra, Nabil
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects with Advanced Solid Tumors
DescriptionThis is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase is no longer enrolling. The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma, and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).
Key Eligibility

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Pathologically confirmed advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
  • Progressive disease, either measurable on physical examination or imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor marker(s).

For a full list of participation criteria, please visit clinicaltrials.gov.

Applicable Disease SitesProstate
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu