Advanced Solid Tumors
Conditions
Interventions
Atezolizumab: Atezolizumab(Genetical Recombination) 1680 mg once every 4 weeks by intravenous infusion.
Sponsors
Shunichiro Iwasawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with ECOG PS of 0 or 1 - Patients who are expected to survive at least 12 weeks from the start of treatment with the investigational drug - Patients with histologically or cytologically confirmed solid tumors - Patients with advanced or recurrent cancer that has not responded to standard of care or patients who are nonresponsive or intolerant to standard of care - Patients with imaging lesions evaluable by RECIST v1.1
Exclusion criteria
Exclusion criteria: - Patients who have received antibody drugs against CTLA-4, PD-1, or PD-L1 in the past and discontinued them because of side effects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Phamacokinetics - Dose-limiting toxicity (DLT) - Safety ( incidence of adverse events, severity assessed by NCI CTCAE v5.0, timing of incidence, etc.) - Serum concentration and pharmacokinetic parameters (AUC, Cmax, etc.) of atezolizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - Efficacy in terms of tumor response, duration of response, progression free survival based on RECIST v1.1 and immunogenicity. | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed