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A First in Man Study of MABp1 in Patients With Advanced Cancers

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ClinicalTrials.gov Identifier: NCT01021072
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.

Brief Summary:

The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process.

An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.


Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: MABp1 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MABp1 in Patients With Advanced Cancers
Study Start Date : March 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: MTD
The study will utilize a standard 3+3 design for dose escalation. Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored.
Drug: MABp1
0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.



Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Tumor response [ Time Frame: one year ]
  2. Cachexia Response [ Time Frame: 8 weeks ]
    Change in LBT as measured by DEXA



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for >/= 3 months
  • measurable or non-measurable disease at baseline
  • at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
  • will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
  • age >/= 18 year, male or female
  • Eastern Cooperative Oncology Group performance status 0,1,or 2
  • Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the low limit of normal.
  • Adequate renal function, defined by serum creating </= 1.5 x ULN
  • Adequate hepatic function
  • Adequate bone marrow function WOCBP, a negative serum pregnancy test result at screening.
  • WOCBP or men whose sexual partners are WOCBP who are willing to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
  • Signed and dated IRB approved ICF before any protocol specific screening procedures are performed

Exclusion Criteria:

  • serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy.
  • Uncontrolled or significant cardiovascular diseae
  • dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • not recovered from the adverse effects of prior therapy at the time of enrollment </= grade 1
  • symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy
  • received extensive prior radiation therapy to the bone marrow
  • immunocompromised, including subjects know to be infected with HIV
  • history of hypersensitivity to compounds of similar chemical or biologic composition to the antibody women how are pregnant or breastfeeding
  • WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021072


Locations
United States, Texas
M.D. Anderson Cancer Institute
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
XBiotech, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01021072     History of Changes
Other Study ID Numbers: 2009-PT004
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Neoplasms