A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers
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
Sponsor: Celldex Therapeutics
A PHASE1 clinical study on Any T-cell Malignancy and Burkett's Lymphoma, this trial is completed. The trial is conducted by Celldex Therapeutics and has accumulated 7 data snapshots since 2011. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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 and T-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 dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127. This 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 Expansion phase, cohorts of approximately 15 patients each 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. Expansion cohorts may be limited to one or more tumor types. 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...
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 and T-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 dose escalation portion of the study will be assigned to one of 5 dose levels of CDX-1127. This 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 Expansion phase, cohorts of approximately 15 patients each 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. Expansion cohorts may be limited to one or more tumor types.
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.
Status Flow
Change History
7 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
-
Feb 2018 — Jun 2018 [monthly]
Completed PHASE1
Status: Active Not Recruiting → Completed
▶ Show 2 earlier versions
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Feb 2017 — Feb 2018 [monthly]
Active Not Recruiting PHASE1
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE1
First recorded
Oct 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Celldex Therapeutics
For direct contact, visit the study record on ClinicalTrials.gov .