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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01021072

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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

Actual Study Start Date :

Mar 31, 2010

Actual Primary Completion Date :

Oct 31, 2012

Actual Study Completion Date :

Aug 31, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose [one year]

Secondary Outcome Measures

Tumor response [one year]
Cachexia Response [8 weeks]
Change in LBT as measured by DEXA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	M.D. Anderson Cancer Institute	Houston	Texas	United States	77030
2	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT01021072

Other Study ID Numbers:

2009-PT004

First Posted:

Nov 26, 2009

Last Update Posted:

Feb 16, 2021

Last Verified:

Feb 1, 2021

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Feb 16, 2021