A Study of CDX-1127 in Patients With Select Solid Tumor Types or Hematologic Cancers
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Purpose
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 | Intervention | 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: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety 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 |
- 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.
- 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 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 |
Inclusion Criteria:
Among other criteria, patients must meet the following conditions to be eligible for the study:
- 18 years of age or older
- Body Weight ≤ 120 kg
- Histologic diagnosis of either a B-cell hematologic malignancy known to express CD27 or one of the following solid tumors: metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer
- Tumor must be recurrent or treatment refractory with no remaining alternative, approved therapy options
- Measurable or evaluable disease
- Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
- If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
- Have little or no side effects remaining from prior cancer therapies.
- Provide written informed consent
Exclusion Criteria:
Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Known prior primary or metastatic brain or meningeal tumors
- Receiving treatment with immunosuppressive agents, including any systemic steroids.
- Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C
- Is being treated for anti-coagulation (i.e. warfarin) for reasons other than catheter patency
- Women who are pregnant or lactating
- Prior allogeneic bone marrow transplant
- Autologous bone marrow transplant within 100 days of first dosing
- Recent chemotherapy or other anti-cancer therapy (within 2 - 14 weeks depending on treatment type)
- Systemic radiation therapy within 4 weeks or prior focal radiotherapy within 2 weeks prior to first dosing
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Arizona - Cancer Clinical Research Unit | Recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Charanjit Singh, CRC 480-301-6046 singh.charanjit@mayo.edu | |
| Principal Investigator: Donald Northfelt, MD | |
| United States, California | |
| Stanford Cancer Center - Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Jennifer Vargas 650-723-0371 jennyv7@stanford.edu | |
| Principal Investigator: Branimir Sikic, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mayo Clinic Clinical Trials Office 507-538-7623 | |
| Principal Investigator: Stephen M. Ansell, M.D, Ph.D. | |
| United States, Ohio | |
| The Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Cynthia Taylor, CCRC 614-293-2366 Cynthia.taylor@osumc.edu | |
| Contact: Jennifer Thurmond jennifer.thurmond@osumc.edu | |
| Principal Investigator: William Carson, MD | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Drug Development Unit Referral Line 615-339-4214 | |
| Principal Investigator: Howard Burris, MD | |
| United States, Texas | |
| Mary Crowley Cancer Research Centers - Medical City | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Alyssa Roth, CRC 972-566-3061 aroth@marycrowley.org | |
| Principal Investigator: John J. Nemunaitis, MD | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Sasha White 434-982-1902 SNW2Z@virginia.edu | |
| Contact: Kristy Scott, BS 434-982-6714 KS4WW@virginia.edu | |
| Principal Investigator: Geoffrey R Weiss, MD | |
More Information
No publications provided
| Responsible Party: | Celldex Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01460134 History of Changes |
| Other Study ID Numbers: | CDX1127-01 |
| Study First Received: | October 12, 2011 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celldex Therapeutics:
|
CD27 expressing Hematologic 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 |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Carcinoma Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lung Neoplasms Lymphoma Melanoma Ovarian Neoplasms Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone |
Lymphoma, Mantle-Cell Hematologic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013