NCT05769075

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	TY-2136b	Drug: TY-2136b PO, QD or BID Escalation stage: 7 increased dose cohorts from low dose to MTD (from 40mg QD to 420mg QD)
DRUG	TY-2136b	Expansion stage: 4 distinct cohorts The dose for the Expansion stage will be determined based on results from the Escalation stage

Timeline

• Start date: 2023-04-20
• Primary completion: 2025-01-01
• Completion: 2025-10-01
• First posted: 2023-03-15
• Last updated: 2023-04-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study