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Clinical Trials/jRCT2080223357
jRCT2080223357UnknownPhase 1

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

Bristol-Myers Squibb K.K.0 sites15 target enrollmentStarted: TBD
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Trial Snapshot

Phase
Phase 1
Enrollment
15
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Intervention Model
Safety study, Single group assignment, Open label

Eligibility Criteria

Ages
20age old over to No limit (—)
Sex
All

Inclusion Criteria

  • •Subject with advanced and/or metastatic solid tumors which are expected to express mesothelin who received the previous treatment
  • •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

Outcomes

Primary Outcomes

-

Safety and tolerability of BMS-986148. Adverse event and Serious adverse event

Secondary Outcomes

  • PK of the total antibody, active ADC and unconjugated tubulysin
  • Immunogenicity of BMS-986148
  • PK parameters

Investigators

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