NCT05866692

A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase I, Multicenter, Open-label Study of TY-2699a, Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.

Detailed description

To assess the safety and tolerability of TY-2699a when administered as a single agent in subjects with locally advanced or metastatic solid tumors. To determine the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) as a single agent in subjects with locally advanced or metastatic solid tumors. To evaluate the pharmacokinetics (PK) of TY-2699a administered at single and multiple oral doses. To assess the preliminary antitumor activity of TY-2699a as a single agent in subjects with locally advanced or metastatic solid tumors.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	TY-2699a	TY-2699a PO, BID Escalation stage: increased dose cohorts from low dose to MTD Expansion stage: The dose for the Expansion stage will be determined based on results

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2023-05-19
• Last updated: 2023-11-07

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study