Advanced solid tumors not curable with, or not eligible for standard treatment(s)
Conditions
Interventions
investigational material(s)
Generic name etc : DS-7423
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically diagnosed advanced solid tumors which are not curable with, or not eligible for standard treatment(s) - ECOG performance status: 0-1
Exclusion criteria
Exclusion criteria: - History of any of the following events within 6 months prior to start of study treatment myocardial infraction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or cerebral infraction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event, clinically significant pulmonary disease (eg severe COPD or asthma) - History of type I and II diabetes - Patient with a clinically active brain metastasis, or who need drugs to control adverse event - History of pneumonitis - Patients with any severe or uncontrolled intercurrent diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (including evaluation of maximum tolerated dose and recommended phase2 dose) and Pharmacokinetics - To evaluate the safety profile according to CTCAE - To evaluate the pharmacokinetics according to the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| - Preliminary anti-tumor effect - Pharmacodynamics - Preliminary biomarker study - To evaluate anti-tumor effect according to RECIST - To evaluate pharmacodynamics of DS-7423 according to the protocol - To study potential biomarker of DS-7423 activity according to the protocol | — |
Outcome results
None listed