A First in Man Study of MABp1 in Patients With Advanced Cancers
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 24, 2009
Trial Information
Current as of July 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Houston, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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