Clinical trial NCT02884726: Phase 1 Study of Mesothelin-ADC
Official title: A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-31
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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/exclusion criteria could apply

Primary outcomes:
measure: Incidence of AEs (Adverse Events)
timeFrame: Day 1 to 30 days after the last dose of BMS-986148
measure: Incidence of SAEs (Serious Adverse Events)
timeFrame: Day 1 to 30 days after the last dose of BMS-986148
measure: Grade of AEs
timeFrame: Day 1 to 30 days after the last dose of BMS-986148
measure: Grade of SAEs
timeFrame: Day 1 to 30 days after the last dose of BMS-986148
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Day 1 to day 84
measure: Time of maximum observed concentration (Tmax)
timeFrame: Day 1 to day 84
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Day 1 to day 84
measure: Area under the concentration-time curve in one dosing interval [AUC(TAU)]
timeFrame: Day 1 to day 84
measure: Average concentration (Cavg)
timeFrame: Day 1 to day 84
measure: Half life (T-half)
timeFrame: Day 1 to day 84
measure: Trough observed plasma concentration (Ctrough)
timeFrame: Day 1 to day 84
measure: Concentration in a dosing interval (Ctau)
timeFrame: Day 1 to day 84
measure: Total body clearance (CLT)
timeFrame: Day 1 to day 84
measure: Apparent volume of distribution at steady state (Vss)
timeFrame: Day 1 to day 84
measure: Volume of distribution of terminal phase (Vz)
timeFrame: Day 1 to day 84
measure: AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC)
timeFrame: Day 1 to day 84
measure: Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax)
timeFrame: Day 1 to day 84
measure: Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau)
timeFrame: Day 1 to day 84
measure: Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Day 1 to 30 days after the last dose of BMS-986148
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: