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A Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics Study

2019-11-11 17:49:19 | BioPortfolio

Summary

The purpose of this study is to determine the safety and tolerability of TAK-573 in participants with locally advanced or metastatic solid tumors.

Description

The drug being tested in this study is called TAK-573. TAK-573 is being tested to evaluate the safety, tolerability, PK, and pharmacodynamics in participants with locally advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase.

The study will enroll approximately 105 participants (approximately 30 participants in dose escalation phase and approximately 75 participants in dose expansion phase).

The dose escalation phase will enroll participants with solid tumors. The dose escalation phase is to evaluate single agent recommended phase 2 dose (RP2D) which could be either MTD or PAD.

The dose expansion phase will be initiated once the MTD and /or PAD are determined for TAK-573. The dose expansion phase will enroll participants in 3 cohorts for participants with NSCLC, CRPC, or with other (not NSCLC or CRPC) advanced or metastatic solid tumors previously treated with an immune checkpoint inhibitor (CPI).

This multi-center trial will be conducted in the United States. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor. The overall time to participate in this study is 43 months. All participants will make an end of treatment (EOT) visit 30 days after receiving their last dose of study drug or before the start of subsequent systemic anticancer therapy, whichever occurs first for a safety follow up assessment.

Study Design

Conditions

Solid Neoplasms

Intervention

TAK-573

Status

Not yet recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-11T17:49:19-0500

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