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A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

NCT00441337•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

Detailed Description

Six patients enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining 10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive additional doses of drug.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma
•Prior treatment must have been completed at least 4 weeks prior to enrollment
•No untreated primary or metastatic brain or meningeal tumors
•ECOG PS 0 or 1
•Meet all screening laboratory values

Exclusion Criteria

•History of severe hypersensitivity reactions to other monoclonal antibodies
•Active autoimmune disease or a documented history of autoimmune disease
•Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
•Active infection
•Concurrent medical condition requiring the use of immunosuppressive medications

Locations (4)

Johns Hopkins Unv., School of Medicine

Baltimore, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University School of Medicine - Barnes Jewish Hospital

St Louis, Missouri, United States

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, United States

Key Dates

Start Date

August 1, 2006

Primary Completion Date

November 1, 2009

Completion Date

November 1, 2009

Last Updated

February 20, 2015

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell LungColorectal CancerMalignant MelanomaRenal CancerProstate Cancer

Interventions

MDX-1106

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)