Spots Global Cancer Trial Database for A Study of TY-2136b in Patients With Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations

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Trial Identification

Brief Title: A Study of TY-2136b in Patients With Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations

Official Title: A Phase I, Multicenter, Open-label Study of TY-2136b, Administered Orally in Patients With Advanced or Metastatic Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Alterations

Study ID: NCT05769075

Conditions

Locally Advanced Solid Tumor

Metastatic Solid Tumor

Interventions

TY-2136b

Study Description

Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose (RP2D), with dose-escalation stage and dose-expansion stage.

Detailed Description: * To evaluate the pharmacokinetic (PK) characteristics of TY-2136b after single and multiple oral doses. * To assess preliminary antitumor activity of TY-2136b as a single agent when administered orally to patients with advanced or metastatic solid tumors. * To identify mutations in the ALK, ROS1 and NTRK1-3, or other molecular alterations in blood or tumor tissues associated with clinical outcome.