Phase 1 Study of Mesothelin-ADC

A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors

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 Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: BMS-986148

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986148 intravenous infusion	Drug: BMS-986148; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs (Adverse Events)	AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline	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	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	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	Day 1 to 30 days after the last dose of BMS-986148

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	Day 1 to day 84
Time of maximum observed concentration (Tmax)	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)]	Day 1 to day 84
Area under the concentration-time curve in one dosing interval [AUC(TAU)]	Day 1 to day 84
Average concentration (Cavg)	Day 1 to day 84
Half life (T-half)	Day 1 to day 84
Trough observed plasma concentration (Ctrough)	Day 1 to day 84
Concentration in a dosing interval (Ctau)	Day 1 to day 84
Total body clearance (CLT)	Day 1 to day 84
Apparent volume of distribution at steady state (Vss)	Day 1 to day 84
Volume of distribution of terminal phase (Vz)	Day 1 to day 84
AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC)	Day 1 to day 84
Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax)	Day 1 to day 84
Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau)	Day 1 to day 84
Response Evaluation Criteria in Solid Tumors (RECIST)	Day 1 to 30 days after the last dose of BMS-986148

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2016
• Primary Completion (Actual): September 6, 2017
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CA008-008