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Completed

NCT Number: NCT02884726

Phase 1 Study of Mesothelin-ADC

The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors.

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Key information

Conditions

Advanced Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Chuo-ku, Tokyo, 1040045, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986148

Drug

Specified dose on specified days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2016
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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