進行固形腫瘍患者を対象としたSTX-478の単剤療法および他の抗腫瘍剤との併用療法に関するヒト初回臨床試験

基本情報

NCT ID

NCT05768139

ステータス

募集中

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

720

治験依頼者名

Eli Lilly and Company

概要

Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.

対象疾患

介入

依頼者（Sponsor）

実施施設 (4)