Phase 1 Study of Mesothelin-ADC

Study Overview
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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.

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: BMS-986148


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986148 intravenous infusion<br> | Drug: BMS-986148<br>* Specified dose on specified days<br>|

What is the study measuring?
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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 | Measure Description | 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 |