A 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 unconfirmed · Phase 2
Conditions studied: Advanced Solid Tumors, CRPC, mCRPC, Metastatic Castrate-resistant Prostate Cancer, PT-112, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site
In brief
This 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 complete and 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 (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).
Key facts
- Study ID
- NCT02266745
- Run by
- Promontory Therapeutics Inc.
- People needed
- 109
- Starts
- 2014-07-01
- Expected to finish
- 2025-04-01
- Last updated by the study team
- 2024-04-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Arizona — Phoenix, Arizona, United States
- Tucson — Tucson, Arizona, United States
- Duarte — Duarte, California, United States
- Colorado — Aurora, Colorado, United States
- Jacksonville — Jacksonville, Florida, United States
- Orlando — Orlando, Florida, United States
- Indianapolis — Indianapolis, Indiana, United States
- Boston — Boston, Massachusetts, United States
- Minneapolis — Minneapolis, Minnesota, United States
- Rochester — Rochester, Minnesota, United States
- Omaha — Omaha, Nebraska, United States
- Albuquerque — Albuquerque, New Mexico, United States
- Brooklyn — Brooklyn, New York, United States
- New York — New York, New York, United States
- Durham — Durham, North Carolina, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Seattle — Seattle, Washington, United States
- Besançon — Besançon, France
- Bordeaux — Bordeaux, France
- Caen — Caen, France
- Clermont-Ferrand — Clermont-Ferrand, France
- Marseille — Marseille, France
- Nice — Nice, France
- Paris — Paris, France
- Rennes — Rennes, France
Full record on ClinicalTrials.gov
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