JPRN-jRCT2080221527CompletedPhase 1
A Phase I study of WT4869 in patients with advanced solid malignancies
Chugai Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma. Co., Ltd.0 sites25 target enrollmentStarted: July 29, 2011Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
This study was conducted to evaluate the safety of WT4869 in patients with advanced solid tumors and to evaluate the MTD of WT4869. In addition, efficacy and biomarkers were exploratory examined. No DLT occurred during the DLT evaluation in both the intradermal and subcutaneous cohorts, suggesting that neither the intradermal cohort nor the subcutaneous cohort reached MTD at the doses studied in this study. Drug was well tolerated in both the intradermal and subcutaneous cohorts.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •- Histologically or cytologically confirmed solid malignancies
- •- HLA-A*2402
- •- Advanced cancer patient who is refractory to standard therapy or no established treatment exists
Exclusion Criteria
- •- Concomitant infection requiring systemic administration of antibiotics or antiviral drugs
- •- Positive for either HIV antibody, HBs antigen or HCV antibody testing within 90 days before entry
- •- Brain metastasis which is symptomatic or requiring treatment, excluding primary malignant brain tumor
Investigators
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