Phase 1 Study of Mesothelin-ADC

NCT ID: NCT02884726

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-14

Study Completion Date

2017-09-06

Brief Summary

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

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986148 intravenous infusion

Group Type EXPERIMENTAL

BMS-986148

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986148

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA008-008

Identifier Type: -

Identifier Source: org_study_id

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