Phase 1 Study of Mesothelin-ADC

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: BMS-986148

• Registration Number: NCT02884726
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Study Start: 2016-10-14
• Primary Completion: 2017-09-06
• Study Completion: 2017-09-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986148 intravenous infusion	BMS-986148	-

Primary Outcome Measures

Name	Time	Method
Incidence of SAEs (Serious Adverse Events)	Day 1 to 30 days after the last dose of BMS-986148	SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Grade of SAEs	Day 1 to 30 days after the last dose of BMS-986148	SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Incidence of AEs (Adverse Events)	Day 1 to 30 days after the last dose of BMS-986148	AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Grade of AEs	Day 1 to 30 days after the last dose of BMS-986148	AE leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline

Secondary Outcome Measures

Name	Time	Method
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
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
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 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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-ku, Tokyo, Japan