Phase 1 Study of Mesothelin-ADC

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: BMS-986148

Study type: Interventional

Funder types: Industry

Identifiers

NCT02884726

CA008-008

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors.

Enrollment: 8 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have histological confirmation of advanced and/or metastatic solid

tumors which are expected to express mesothelin

• Must have received and either progressed or been intolerant to the standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
• Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

• Cancer metastases in the brain
• Uncontrolled or significant cardiovascular disease
• Moderate eye disorders
• Moderate peripheral neuropathy
• Known past or active hepatitis B or C infection

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BMS-986148 intravenous infusion

Experimental group

Treatment:

Drug: BMS-986148