Advanced Cancer
Conditions
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.
Interventions
DRUGBMS-986148
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) | 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 |
| Trough observed plasma concentration (Ctrough) | 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 |
| Maximum observed concentration (Cmax) | Day 1 to day 84 |
Countries
Japan
Outcome results
None listed