Solid tumor (urothelial carcinoma, and so on)
Conditions
Interventions
investigational material(s)
Generic name etc : TAS0313
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent for participate in clinical trial 2. Has histologically or cytologically confirmed solid tumor(s) for which standard therapy has been performed 3. Has been confirmed to have any of the following genotypes by human leukocyte antigen (HLA) genotyping test: HLA-A*02:01, -A*02:06, -A*02:07, -A*11:01, -A*24:02, -A*31:01, and -A*33:03 4. Has a history of two or less chemotherapy regimens and meets any of the following (Cohort C1). a) Received standard therapy including a platinum drug for unresectable locally advanced or metastatic urothelial carcinoma. b) Received standard pre/post-operative adjuvant therapy including a platinum drug for localized muscle-invasive urothelial carcinoma, which was confirmed to recur or progress within 12 months after the end of the therapy. 5. Has demonstrated disease progression after pembrolizumab for unresectable locally advanced or metastatic urothelial carcinoma (Cohort C2).
Exclusion criteria
Exclusion criteria: 1. Has serious diseases or conditions 2. Has a history of hypersensitivity to drugs in classes related to TAS0313, any excipient of TAS0313 3. Pregnant or lactating women or women of child-bearing potential who have a positive pregnancy test (urine or serum) within seven days prior to enrollment 4. Has received prior therapy with immunotherapy agents (Cohort C1) 5. Has received prior therapy with immunotherapy agents and was discontinued from that treatment due to irAE (Cohort C2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Tolerability, Safety, Efficacy NCI CTCAE v4.03 RECIST Version1.1 iRECIST RANO for High grade glioma iRANO | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamics pharmacogenomics pharmacodynamics, pharmacogenomics | — |
Countries
Japan
Outcome results
None listed