Phase 1 Study of BMS-986148
Phase 1
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2080223357
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of BMS-986148.<br>Adverse event and Serious adverse event
- Secondary Outcome Measures
Name Time Method Preliminary anti-tumor activity of BMS-986148<br>To characterize the PK of the total antibody, active ADC and unconjugated tubulysin<br>To characterize the immunogenicity of BMS-986148<br>Response Evaluation Criteria<br>The following PK parameters of total antibody, active ADC and unconjugated tubulysin: Cmax, Tmax, AUC(0-T), AUC(TAU), Cavg, T-HALF, Ctrough, Ctau, CLT, Vss, Vz, AI_AUC, AI_Cmax and AI_Ctau<br>Immunogenicity status