Phase 1 Study of Mesothelin-ADC

Bristol-Myers Squibb8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Cancer

Interventions

BMS-986148DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of AEs (Adverse Events)

AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Time frame: Day 1 to 30 days after the last dose of BMS-986148

Incidence of SAEs (Serious Adverse Events)

SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Time frame: Day 1 to 30 days after the last dose of BMS-986148

Grade of AEs

AE leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Time frame: Day 1 to 30 days after the last dose of BMS-986148

Grade of SAEs

SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Time frame: Day 1 to 30 days after the last dose of BMS-986148

Secondary Outcomes

Maximum observed concentration (Cmax)

Time frame: Day 1 to day 84

Time of maximum observed concentration (Tmax)

Time frame: Day 1 to day 84

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

Time frame: Day 1 to day 84

Area under the concentration-time curve in one dosing interval [AUC(TAU)]

Time frame: Day 1 to day 84

Average concentration (Cavg)

Data from ClinicalTrials.gov

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