NCT06037317

A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors

A Phase Ib, Multi-center, Open-Lable, Dose-Escalation and Dose-Expansion Study of Efficacy and Safety of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multicenter, phase Ib study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic, LTK fusion-positive solid tumor who have progressed on or are intolerant to prior standard therapy.

Detailed description

The study will be conducted in 2 parts: Dose-escalation phase: Participants will be allocated to one of the three dose groups of 500mg, 600mg, or 800mg and receive a single dose of SY-3505 capsules, followed by a 7-day safety observation period and pharmacokinetic (PK) assessment. Subsequently, SY-3505 will be administered once daily in 28-day treatment cycles. This phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the safety, tolerability and PK of SY-3505 in patients with LTK fusion-positive solid tumors. Dose-expansion phase: Participants will be assigned to one of the 1-2 dose groups determined during the dose-escalation phase, and receive SY-3505 capsules once daily in 28-day treatment cycles. This phase is designed to evaluate the anti-tumor activity (ORR, DCR and DOR) of SY-3505 in patients with LTK fusion-positive solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SY-3505	LTK tyrosine kinase inhibitor

Timeline

• Start date: 2024-05-30
• Primary completion: 2025-12-30
• Completion: 2026-05-30
• First posted: 2023-09-14
• Last updated: 2024-02-02

Locations

1 site across 1 country: China