Phase 1 Study of Mesothelin-ADC

Advanced Cancer Clinical Trial

Official title:

A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884726
• Other study ID #: CA008-008
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2016
• Est. completion date: September 6, 2017

Study information

• Verified date: March 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 6, 2017
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• BMS-986148
Specified dose on specified days

Locations

Country	Name	City	State
Japan	Local Institution	Chuo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Maximum observed concentration (Cmax)		Day 1 to day 84
Secondary	Time of maximum observed concentration (Tmax)		Day 1 to day 84
Secondary	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
Secondary	Area under the concentration-time curve in one dosing interval [AUC(TAU)]		Day 1 to day 84
Secondary	Average concentration (Cavg)		Day 1 to day 84
Secondary	Half life (T-half)		Day 1 to day 84
Secondary	Trough observed plasma concentration (Ctrough)		Day 1 to day 84
Secondary	Concentration in a dosing interval (Ctau)		Day 1 to day 84
Secondary	Total body clearance (CLT)		Day 1 to day 84
Secondary	Apparent volume of distribution at steady state (Vss)		Day 1 to day 84
Secondary	Volume of distribution of terminal phase (Vz)		Day 1 to day 84
Secondary	AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC)		Day 1 to day 84
Secondary	Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax)		Day 1 to day 84
Secondary	Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau)		Day 1 to day 84
Secondary	Response Evaluation Criteria in Solid Tumors (RECIST)		Day 1 to 30 days after the last dose of BMS-986148

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form