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NCT02642016 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors

A Phase 1 study of Advanced Cancer, sponsored by Celldex Therapeutics.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
4
Study locations

NCT02642016 is a Phase 1 study of Advanced Cancer that has completed, run by Celldex Therapeutics. The registered enrollment target is 28 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT02642016, a Phase 1 study of Advanced Cancer, has completed, sponsored by Celldex Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target
4
Study locations

Study Summary

This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.

Conditions Studied

Interventions

  • BIOLOGICAL CDX-0158 (formerly known as KTN-0158)

Study Locations (4)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

Oregon

  • Oregon Health & Sciences University - Portland

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2015-12
Est. Completion 2019-06-04
Phase Phase 1

Sponsor

Celldex Therapeutics

42 total trials

What the Registry Record Tells You About NCT02642016

The ClinicalTrials.gov registry entry for NCT02642016 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Celldex Therapeutics, which has 42 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention - of which CDX-0158 (formerly known as KTN-0158) is the first listed.

NCT02642016 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, Oregon, Tennessee.

Frequently Asked Questions

What is clinical trial NCT02642016 about?

NCT02642016 is a clinical study titled "A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid Tumors". This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of CDX-0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.

What is the current status of trial NCT02642016?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-12. Estimated completion is 2019-06-04.

What conditions does trial NCT02642016 study?

This clinical trial studies the following conditions: Advanced Cancer.

What interventions are being tested in trial NCT02642016?

The interventions under investigation include: CDX-0158 (formerly known as KTN-0158) (BIOLOGICAL).

Who is sponsoring clinical trial NCT02642016?

This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02642016 being conducted?

This trial has 4 study locations across Massachusetts, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.