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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986148 intravenous infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986148 | Drug | Specified dose on specified days |
|
| 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 |
| 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)] |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
tumors which are expected to express mesothelin
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Chuo-ku | Tokyo | 1040045 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| 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 |