Advanced or metastatic solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : INCMGA00012
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : intravenou
Sponsors
Incyte Biosciences Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Participant is Japanese 2 Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors not amenable to local or other curative therapy. 3 Participants with nonevaluable lesions are allowed. 4 Life expectancy > 3 months. 5 Eastern Cooperative Oncology Group performance status 0 to 1. 6 Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration. 7 Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study. 8 Male participants should avoid unprotected sex with women of childbearing potential and refrain from donating sperm during participation the study.
Exclusion criteria
Exclusion criteria: 1 Receipt of anticancer therapy or participation in another interventional clinical study within 14 days before the first administration of study drug with the following exceptions: Immunotherapy or biological therapy (eg, monoclonal antibodies) within 21 days the first administration of study drug; 6 weeks for mitomycin-C or nitrosoureas; 7 days for tyrosine kinase inhibitors. 2 Radiotherapy within 14 days of first dose of study treatment with the following exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy. 3 Toxicity of prior therapy and/or complications from surgical intervention that has not recovered to 10 mg of prednisone or equivalent). 7 Known active central nervous system metastases and/or carcinomatous meningitis. 8 Known active hepatitis A virus, hepatitis B virus, or hepatitis C virus infection. 9 Known HIV infection. 10 Active infections requiring systemic therapy. 11 Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures and/or known hypersensitivity >- Grade 3, or severe reaction, to study treatments or any of their excipients or additives. 12 Participants with impaired cardiac function or clinically significant cardiac disease. 13 Evidence of interstitial lung disease or active, noninfectious pneumonitis or a history of interstitial lung disease. 14 Participant is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety 1 Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012 2 Number of treatment-emergent adverse events in participants receiving single-agent INCB00115 3 Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012 | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics 1. Part 1: Pharmacokinetics of single-agent of INCMGA000012 and INCB001158. 2. Part 2: Pharmacokinetics of combination of INCMGA000012 and INCB001158 3. Part 1 and Part 2: Duration of response with INCMGA00012 and INCB001158, and combination of both agents. | — |
Countries
Japan
Outcome results
None listed