SNPMiner Trials (Home Page)
Report for Clinical Trial NCT01460134
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
Name: CDX-1127
Description: Patients will initially receive a single dose of CDX-1127, followed by a 28-day observation period and a Multi-Dose Phase (one "cycle" of 4 weekly doses of CDX-1127). All patients with stable disease who do not experience a 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.
Type: Drug
Group Labels: 2 Hematologic Malignancies (Dose Escalation) Solid tumors (Dose Escalation; COMPLETED)
Name: CDX-1127
Description: Patients will receive 4 weekly doses of CDX-1127 followed by an observation period. All patients with stable disease who do not experience a 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.
Type: Drug
Group Labels: 1 Solid Tumors (Expansion Phase; COMPLETED)
Name: CDX-1127
Description: Patients will receive four doses of CDX-1127 administered every three weeks followed by an observation period. All patients with stable disease who do not experience a 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.
Type: Drug
Group Labels: 1 Hematologic Malignancies (COMPLETED)
Primary Outcomes
Description: Analysis 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.
Measure: Characterize the adverse events associated with CDX-1127 administration
Time: Safety follow up is 70 days from last dose.
Secondary Outcomes
Measure: Levels of anti-CD27 antibodies in circulating blood.
Time: Until end of treatment
Measure: Levels of CDX-1127 in circulating blood.
Time: Until end of treatment
Description: Determine the anti-malignant cell activity of CDX-1127 based on change from baseline in tumor measurements every 12 weeks.
Measure: Activity Evaluations
Time: Until disease progression
Measure: Immune system effects (eg: lymphoid cell populations and serum cytokine levels)
Time: Until end of treatment
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There is one SNP
SNPs
1 V600E
4. Tumor must be recurrent or treatment refractory with no remaining alternative,
approved therapy options, with the following exception: melanoma patients enrolled in
the expansion phase must have previously received ipilimumab and, for patients with
the BRAF V600E mutation, vemurafenib, or have been offered such therapies and refused,
and patients must have progressive disease subsequent to previous therapies. --- V600E ---