A Phase 1 Study of ASP1951 in Subjects With Advanced Solid Tumors
18 Years and older, Male and Female
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951; and determine the recommended phase 2 dose (RP2D) of ASP1951 and / or maximum tolerated dose (MTD). This study will also evaluate the anti-tumor effect of ASP1951.
This is a dose-escalation and expansion study of ASP1951. 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 ASP1951 in participants with
locally advanced (unresectable) or metastatic solid tumor malignancies including but not
limited to squamous cell carcinoma of the head and neck, colorectal cancer, prostate cancer
and cervical cancer.
For dose expansion, the tumor-specific cohorts will include participants with any tumor types
that respond to study drug treatment during dose escalation.
Participants may reinitiate study drug treatment in the optional Re-treatment period after
confirmation that the participant meets all the re-treatment eligibility criteria.
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.