A First in Man Study of MABp1 in Patients With Advanced Cancers
This study is ongoing, but not recruiting participants.
Sponsor:
XBiotech, Inc.
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01021072
First received: November 16, 2009
Last updated: August 28, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: MABp1 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of MABp1 in Patients With Advanced Cancers |
Resource links provided by NLM:
Further study details as provided by XBiotech, Inc.:
Primary Outcome Measures:
- Maximum tolerated dose [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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
| Enrollment: | 52 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | XBiotech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01021072 History of Changes |
| Other Study ID Numbers: | 2009-PT004 |
| Study First Received: | November 16, 2009 |
| Last Updated: | August 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013