A phase 1 clinical study of WT2725 in patients with advanced solid malignancies.
- Conditions
- Advanced solid malignancies
- Registration Number
- JPRN-jRCT2080222290
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
This study was conducted to assess the safety of WT2725 in patients with advanced solid tumors, to determine MTDs, and to exploratory evaluate efficacy and biomarkers. No DLT was observed in any of the cohorts, and due to a change in the development plan, three additional patients were added to Cohort 2, and the MTD could not be determined because they were not evaluated in six patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 8
out-patient
Main Inclusion criteria
- Patients >= 20 year old at informed consent
- ECOG performance status: 0 or 1
- Histologically or cytologically diagnosed as solid tumor
- Refractory to standard treatment or no standard treatment is established
Main Exclusion criteria
- Positive for HIV and HCV antibody, HBV surface antigen within 90 days prior to enrollment
- Symptomatic brain metastasis
- Previous treatment with WT2725 or WT1 peptide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety<br>- Maximum tolerated dose (MTD)<br>- Adverse Event, side effect<br>- clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results, chest X-ray examination
- Secondary Outcome Measures
Name Time Method efficacy<br>Efficacy<br>Tumor assessment