A Study of CDX-1127 in Patients With Select Solid Tumor Types or Hematologic Cancers

This study is currently recruiting participants.
Verified June 2012 by Celldex Therapeutics

First Received on October 12, 2011.  
Last Updated on June 25, 2012  
History of Changes
This Clinical Trial Sponsored By: Celldex Therapeutics
Information provided by (Responsible Party): Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT01460134
 

Purpose for Clinical Trial

This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.

Condition Study Intervention Clinical Trial Phase
CD27 Expressing B-cell Malignancies
CD27 Expressing Solid Tumors
Chronic Lymphocytic Leukemia
Burkett’s Lymphoma
Mantle Cell Lymphoma
Primary Lymphoma of the Central Nervous System
Marginal Zone B Cell Lymphoma
Solid Tumor
Metastatic Melanoma
Renal (Clear) Cell Carcinoma
Hormone-refractory Prostate Adenocarcinoma
Ovarian Cancer
Colorectal Adenocarcinoma
Non-small Cell Lung Cancer
Drug: CDX-1127 Phase 1

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Lung Cancer
Lymphoma
Melanoma
Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures For Clinical Trial:

  • Number of reported adverse events [ Time Frame: Until day 70 follow up. ] [ Designated as safety issue: Yes ]
    The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX-1127.

Secondary Outcome Measures For Clinical Trial:

  • Levels of anti-CD27 antibodies in circulating blood [ Time Frame: Until day 70 follow up ] [ Designated as safety issue: No ]
  • Levels of CD27 in circulating blood [ Time Frame: Until day 70 of follow up ] [ Designated as safety issue: No ]
  • Activity Evaluations [ Time Frame: Until day 70 of follow up ] [ Designated as safety issue: No ]
    Determine the anti-malignant cell activity of CDX-1127 based on change from baseline in tumor measurements every 12 weeks.

  • Immune system effects (eg: lymphoid cell populations, serum cytokines, and response to recall antigens and vaccination). [ Time Frame: Until day 70 of follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Hematologic Malignancies

This Phase 1 dose-escalation safety and PK study will be conducted in patients with hematologic malignancies known to express CD27
Drug: CDX-1127

Patients will initially receive a single dose of CDX 1127, followed by a 28-day observation period and a Multiple-Dose Phase (one "cycle" of 4 weekly doses of CDX-1127). Patients enrolled into the expansion cohort(s) will start treatment with the multi-dose phase. All patients with stable disease who do not experience DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional "cycles"). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression.

The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127.

Experimental: Solid tumors

This Phase 1 dose-escalation safety and PK study will be conducted in patients with solid tumors which express CD27.
Drug: CDX-1127

Patients will initially receive a single dose of CDX 1127, followed by a 28-day observation period and a Multiple-Dose Phase (one "cycle" of 4 weekly doses of CDX-1127). Patients enrolled into the expansion cohort(s) will start treatment with the multi-dose phase. All patients with stable disease who do not experience DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional "cycles"). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression.

The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127.

Detailed Description:

CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and also on certain hematologic tumor cells and may act to promote anti-tumor effects.

This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients with B-cell hematologic malignancies known to express CD27 and solid tumors that are more likely to be responsive to the immune system.

Eligible patients who enroll in the study will be assigned to one of 5 dose levels of CDX-1127. The first phase of the study will test the safety profile of CDX-1127 and will assess which dose to test in future studies.

During the second phase, up to 30 patients will receive the study treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has an effect on their cancer. Patients enrolled in the study may receive study treatment for up to 5 cycles, until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons.

All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the study:

  1. 18 years of age or older

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