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A Phase 1 Study of ASP1951 in Subjects With Advanced Solid Tumors

Status
Active
Cancer Type
Lung Cancer
Prostate Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03799003
Protocol IDs
1951-CL-0101 (primary)
NCI-2019-02414
Study Sponsor
Astellas Pharma Global Development, Inc.

Summary

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.

Objectives

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.
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