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ACTIVE NOT RECRUITING Phase 2

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

NCT02266745 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG PT-112 Injection

Study Locations (20)

Other

  • Besançon — Besançon
  • Bordeaux — Bordeaux
  • Caen — Caen

Arizona

  • Arizona — Phoenix
  • Tucson — Tucson

Florida

  • Jacksonville — Jacksonville
  • Orlando — Orlando

Minnesota

  • Minneapolis — Minneapolis
  • Rochester — Rochester

New York

  • Brooklyn — Brooklyn
  • New York — New York

California

  • Duarte — Duarte

Colorado

  • Colorado — Aurora

Indiana

  • Indianapolis — Indianapolis

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2014-07
Est. Completion 2025-04-01
Phase Phase 2

Sponsor

Promontory Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02266745

The ClinicalTrials.gov registry entry for NCT02266745 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Promontory Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 9 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which PT-112 Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02266745 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02266745 about?

NCT02266745 is a clinical study titled "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". 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 Inject...

What is the current status of trial NCT02266745?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2014-07. Estimated completion is 2025-04-01.

What conditions does trial NCT02266745 study?

This clinical trial studies the following conditions: Advanced Solid Tumors, Prostatic Neoplasms, Neoplasms by Site, Urogenital Neoplasms, mCRPC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02266745?

The interventions under investigation include: PT-112 Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02266745?

This trial is sponsored by Promontory Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02266745 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial