NCT05257512

Phase I/II Study of SY-3505 in Patients With ALK-positive Advanced Non-small Cell Lung Cancer

A Phase I/II, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Antitumor Activity of SY-3505 Capsule in Patients With ALK-positive Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II, open-label and multi-center study of SY-3505, a third-generation ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer (ALK-positive NSCLC).

Detailed description

The study consists of two parts: Part 1: Dose-escalation and dose-expansion in patients with advanced ALK-positive NSCLC, including 9 SY-3505 dose levels. Dose-escalation study phase is designed to determine the dose-limiting toxicity (DLT) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of SY-3505. Other dose regimens may be explored based on the analysis of emerging PK and safety data. At this study phase, SY-3505 administered orally once daily (QD) in 28-day treatment cycles to adult patients with ALK-positive NSCLC. Dose-expansion study is designed to evaluate the antitumor activity (ORR, DCR and DoR) of SY-3505 at selected doses in ALK-positive NSCLC patients who have received at least 1 prior ALK TKI therapy. Part 2: Phase 2 study to evaluate the efficacy of SY-3505. This phase is designed to determine the antitumor activity (ORR, DCR, DoR, PFS and OS), safety, and PK of SY-3505 at RP2D in ALK-positive NSCLC patients who have received alectinib only or ≥2 prior ALK TKIs.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SY-3505	The third-generation ALK TKI

Timeline

• Start date: 2020-04-26
• Primary completion: 2024-04-26
• Completion: 2024-08-26
• First posted: 2022-02-25
• Last updated: 2023-02-14

Locations

1 site across 1 country: China