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A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

Study of BMS-986012 in Subjects With Small Cell Lung Caner

Bristol-Myers Squibb K.K.

mg-jp-clinical_trial@bms.com

Interventional

Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

1

Histological or cytological confirmed small cell lung cancer (SCLC)
Eastern Cooperative Oncology Group Performance Status 0-1
at least one measurable lesion that is not amenable to resection.
Adequate organ function

Symptomatic central nervous system (CNS) metastases
Greater than or equal to Grade 2 peripheral neuropathy
Uncontrolled or significant cardiac disease
Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)

Both

Small Cell Lung Cancer

investigational material(s)
Generic name etc : BMS-986012, Cisplatin, Etoposide
INN of investigational material : Cisplatin, Etoposide
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous infusion every 3 weeks

Safety and Tolerability
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs )
Number of Discontinuations due to AEs
Number of Deaths due to AEs
Number of participants with laboratory toxicity grade shift from baseline

Pharmacokinetics (PK)
Immunogenicity
Efficacy
Following PK Parameters: Cmax, Tmax, AUC(0-T), Ctau, AUC(TAU)
Anti-drug antibodies (ADA)
Best overall response (BOR) and duration of response (DOR)