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
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedStudy Start
First participant enrolled
October 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2017
CompletedMarch 19, 2020
March 1, 2020
11 months
August 2, 2016
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (1)
BMS-986148 intravenous infusion
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Chuo-ku, Tokyo, 1040045, Japan
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 31, 2016
Study Start
October 14, 2016
Primary Completion
September 6, 2017
Study Completion
September 6, 2017
Last Updated
March 19, 2020
Record last verified: 2020-03