A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

Status:	Active, not recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/2/2019
Start Date:	June 17, 2015
End Date:	August 29, 2022

A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors

The purpose of this study is to determine the safety, tolerability, pharmacokinetics,
immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and
in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer,
ovarian cancer, pancreatic cancer and gastric cancer.

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For
dose expansion, must have tumor that is positive for mesothelin

- Expected to have life expectancy of at least 3 months

- Men and women 18 years old or older (or local age of majority)

- Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST)
or modified RECIST for malignant pleural mesothelioma

- ECOG of 0 to 1

Exclusion Criteria:

- Cancer metastases in the brain

- Moderate eye disorders

- Active infection or past hepatitis B or C infection

- Major surgery less than 1 month before the start of the study

- Uncontrolled heart disease

- Impaired liver or bone marrow function

- History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal
antibodies, nivolumab or related compounds

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111