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The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 and determine the recommended Phase 2 dose (RP2D) of ASP1948. This study will also evaluate the antitumor effect of ASP1948.
This is a dose-escalation and expansion study of ASP1948. The study consists of 3 periods: screening, treatment and follow up, followed by an optional Re-treatment period for participants that qualify.
The escalation cohorts will evaluate escalating dose levels of ASP1948 in participants with locally advanced (unresectable) or metastatic solid tumor malignancies.
After discontinuation of study drug, all participants will complete an end-of-treatment visit, along with 30-day and 90-day safety follow-up visits.
For dose expansion, the tumor-specific cohorts will include participants with squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, melanoma and breast cancer, as well as any tumor types that respond to study drug treatment during dose escalation.
Advanced Solid Tumors
Not yet recruiting
Astellas Pharma Inc
Published on BioPortfolio: 2018-06-28T05:15:12-0400
The primary purpose of this study is to evaluate the tolerability, safety and pharmacokinetic profile of ASP1948 in Japanese patients with locally advanced (unresectable) or metastatic sol...
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