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COMPLETEDPHASE1

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

A Phase 1 Study of MABp1 in Patients With Advanced Cancers

NCT01021072•Janssen Research & Development, LLC

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+2 more criteria

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

Locations (2)

M.D. Anderson Cancer Institute

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

March 31, 2010

Primary Completion Date

October 31, 2012

Completion Date

August 31, 2013

Last Updated

February 16, 2021

Enrollment

ACTUAL participants

Conditions

Advanced Cancers

Interventions

MABp1

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

Plasmodium Immunotherapy for Advanced Cancers

Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors

A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors

Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer