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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01021072
First received: November 16, 2009
Last updated: October 15, 2013
Last verified: October 2013

November 16, 2009
October 15, 2013
March 2010
October 2012   (final data collection date for primary outcome measure)
Maximum tolerated dose [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01021072 on ClinicalTrials.gov Archive Site
  • Tumor response [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Cachexia Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in LBT as measured by DEXA
Tumor response [ Time Frame: one year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A First in Man Study of MABp1 in Patients With Advanced Cancers
A Phase 1 Study of MABp1 in Patients With Advanced Cancers

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancers
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.
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.
Intervention: Drug: MABp1
Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. 2014 May;15(6):656-66. doi: 10.1016/S1470-2045(14)70155-X. Epub 2014 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
August 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021072
2009-PT004
No
XBiotech, Inc.
XBiotech, Inc.
Not Provided
Not Provided
XBiotech, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP