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| Sponsor: | Xencor, Inc. |
|---|---|
| Information provided by: | Xencor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00606645 |
Purpose
An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 will be conducted to define the MTD or recommended dose(s) for further study, to determine safety and tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior therapeutic regimens. There will be no intra-patient dose escalation.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Lymphoma Anaplastic Large Cell Lymphoma |
Biological: XmAb2513 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Study of Every Other Week XmAb®2513 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma |
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: XmAb2513
XmAb2513 is An anti-CD30 antibody that will be given at doses of 0.3, 1.0, 3.0, 6.0, 9.0 or 12.0 mg/kg
|
A Phase 1 Study of Every Other Week XmAb®2513 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb2513 will be conducted to define the maximum tolerated dose (MTD) or recommended dose(s) for further study, to determine safety and tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior therapeutic regimens. There will be no intra-patient dose escalation.
The trial target Patients who are > 18 years old with a histological diagnosis of Hodgkin Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL [non-cutaneous] ) and who have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant.
Treatment is given every 2 weeks for 4 doses. Patients with complete response (CR), partial response (PR) or stable disease (SD) may continue until progressive disease (PD) or a max of 8 doses. All patients will complete 3 months of follow-up or up to next treatment.
Administration of XmAb2513 (0.3, 1.0, 3.0, 6.0, 9.0 , 12.0 mg/kg) IV over 2 hours. Initial dosing will occur using an accelerated dose escalation design. Dose escalation will be divided into two segments: the initial accelerated escalation phase and the standard escalation phase. During the initial accelerated dose escalation phase, dose escalation may occur after treatment of one patient per cohort provided that there is no DLT and no Grade 2 or greater, treatment-related toxicity. Treatment-related is defined as probably or possibly related to study drug. The dose escalation safety assessment period will include data from the first 4 weeks of treatment (2 doses or one cycle).
At the point that a patient experiences a treatment-related DLT or treatment-related, Grade 2 or greater toxicity (based on the NCI CTCAE version 3) during the dose escalation safety assessment period, the initial accelerated escalation phase will end, the standard dose escalation phase will begin, and the cohort in which the event occurred will be expanded to a total of 3 patients (2 additional patients will be enrolled).
From this point forward the standard 3+3 dose escalation rules will apply (the standard escalation phase). If none of 3 patients have a DLT then dose escalation to the next level will occur. If 1 of the 3 patients experiences a DLT, then the cohort will be further expanded to 6 patients (3 additional patients will be enrolled). If there are no additional patients with a DLT, dose escalation to the next higher dose level will occur. During the dose escalation period, any cohort with 2 or more patients experiencing a DLT will have exceeded the MTD and there will be no further dose escalation.
Safety/tolerability will be assessed by Physical examination, clinical laboratory tests [hematology and blood chemistry, urinalysis, PT/PTT, international normalized ratio (INR)] HAHA, cytokine levels, vital signs, and toxicity assessment.
Clinical disease activity: CT of neck, chest, pelvis and abdomen will be performed at the completion of 8 weeks of therapy, CT/PET will be performed at weeks 8 and 16.
FDG PET scanning will be used to monitor anti-CD30 metabolic effects and incorporated into response criteria.
Blood samples will be analyzed for serum levels of XmAb2513 and soluble CD30. Human anti- XmAb2513 antibodies will also be monitored.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required baseline laboratory data:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anas Younes, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Xencor ( Rolondo Enoch ) |
| Study ID Numbers: | XmAb2513-01 |
| Study First Received: | January 21, 2008 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00606645 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphatic Diseases Neoplasms |
Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma |