Phase 1 Study of Mesothelin-ADC

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02884726
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Drug: BMS-986148	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
• Actual Study Start Date: Oct 14, 2016
• Actual Primary Completion Date: Sep 6, 2017
• Actual Study Completion Date: Sep 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986148 intravenous infusion	Drug: BMS-986148; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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 Outcome Measures

1. Maximum observed concentration (Cmax) [Day 1 to day 84]

2. Time of maximum observed concentration (Tmax) [Day 1 to day 84]

3. 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]

4. Area under the concentration-time curve in one dosing interval [AUC(TAU)] [Day 1 to day 84]

5. Average concentration (Cavg) [Day 1 to day 84]

6. Half life (T-half) [Day 1 to day 84]

7. Trough observed plasma concentration (Ctrough) [Day 1 to day 84]

8. Concentration in a dosing interval (Ctau) [Day 1 to day 84]

9. Total body clearance (CLT) [Day 1 to day 84]

10. Apparent volume of distribution at steady state (Vss) [Day 1 to day 84]

11. Volume of distribution of terminal phase (Vz) [Day 1 to day 84]

12. AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) [Day 1 to day 84]

13. Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) [Day 1 to day 84]

14. Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) [Day 1 to day 84]

15. Response Evaluation Criteria in Solid Tumors (RECIST) [Day 1 to 30 days after the last dose of BMS-986148]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Chuo-ku	Tokyo	Japan	1040045

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02884726
• Other Study ID Numbers: CA008-008
• First Posted: Aug 31, 2016
• Last Update Posted: Mar 19, 2020
• Last Verified: Mar 1, 2020

Study Results

No Results Posted as of Mar 19, 2020