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Phase 1 Study of Mesothelin-ADC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02884726
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
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 : October 14, 2016
Actual Primary Completion Date : September 6, 2017
Actual Study Completion Date : September 6, 2017

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




Primary Outcome Measures :
  1. Incidence of AEs (Adverse Events) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 1 to day 84 ]
  2. Time of maximum observed concentration (Tmax) [ Time Frame: 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)] [ Time Frame: Day 1 to day 84 ]
  4. Area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Day 1 to day 84 ]
  5. Average concentration (Cavg) [ Time Frame: Day 1 to day 84 ]
  6. Half life (T-half) [ Time Frame: Day 1 to day 84 ]
  7. Trough observed plasma concentration (Ctrough) [ Time Frame: Day 1 to day 84 ]
  8. Concentration in a dosing interval (Ctau) [ Time Frame: Day 1 to day 84 ]
  9. Total body clearance (CLT) [ Time Frame: Day 1 to day 84 ]
  10. Apparent volume of distribution at steady state (Vss) [ Time Frame: Day 1 to day 84 ]
  11. Volume of distribution of terminal phase (Vz) [ Time Frame: 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) [ Time Frame: Day 1 to day 84 ]
  13. Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) [ Time Frame: Day 1 to day 84 ]
  14. Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) [ Time Frame: Day 1 to day 84 ]
  15. Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Day 1 to 30 days after the last dose of BMS-986148 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884726


Locations
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Japan
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02884726    
Other Study ID Numbers: CA008-008
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020