Advanced Malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : BMS-986227
INN of investigational material : Cabiralizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investiga
Sponsors
Bristol-Myers Squibb K.K.
Ono Pharmaceutical Co. Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Performance status 0-1 Adequate organ function Cohort M1, 2 and C1: Measurable disease Cohort M1, M2 and C1: Subjects must have histologic or cytologic confirmation of an advanced (metastatic and/or unresectable) malignant solid tumor Cohort C2: Documented refractory or relapsed multiple myeloma Subjects must be refractory to or have relapsed after standard therapies, or have no known effective treatment
Exclusion criteria
Exclusion criteria: Cohort M1, M2, and C1: Untreated or active central nervous system (CNS) or leptomeningeal metastases Cohort M1, M2, and C1: Subjects with hepatocellular carcinoma (HCC) Cohort C2: Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Incidenence of Adverse Events (AEs) [ Time Frame: Up to two years ] Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ] Incidence of laboratory abnormalities [ Time Frame: Up to two years ] Incidence of death [ Time Frame: Up to two years ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory pharmacokinetics pharmacodynamics pharmacogenomics Incidence of AEs [ Time Frame: Up to two years ] Incidence of serious adverse events (SAEs) [ Time Frame: Up to two years ] Incidence of laboratory abnormalities [ Time Frame: Up to two years ] Trough observed concentration (Ctrough) Accumulation Index; ratio of Ctrough at steady-state (AI_Ctrough) [ Time Frame: Up to one year ] Area under the concentration-time curve [ Time Frame: Up to one year ] Maximum observed serum concentration (Cmax) [ Time Frame: Up to one year ] Trough observed concentration (Ctrough) [ Time Frame: Up to one year ] Effective elimination half-life that explains the degree of Ctrough (T-HALFeff_Ctrough) [ Time Frame: Up to one year ] Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to one year ] Volume of distribution at steady state (Vss) [ Time Frame: Up to one year ] Incidence of Antidrug Antibodies (ADA) [ Time Frame: Up to four years ] Best overall response (BOR) [ Time Frame: Up to two years ] Duration of response [ Time Frame: Up to two years ] Incidence of death [ Time Frame: Up to two years ] | — |
Countries
Japan
Outcome results
None listed