ficonalkib (SY-3505) / Shouyao Holdings - LARVOL DELTA

A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC (clinicaltrials.gov) - P3 | N=255 | Not yet recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD

Metastases • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD | Trial completion date: Dec 2025 ➔ May 2026 | Initiation date: Oct 2023 ➔ May 2024 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Solid Tumor • LTK

Ficonalkib (SY-3505) in Advanced ALK-Positive Non-Small-Cell Lung Cancer: A Multicenter, Open-Label, Single-Arm, Phase I/Ⅱ Study. (PubMed, J Thorac Oncol) - P1/2 | "Ficonalkib (SY-3505) was well tolerated, with favorable safety profiles and promising efficacy in patients resistant to prior 2-gen ALK TKI."

Journal • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Shoudao Holdings (688197.SH): The third-generation ALK kinase inhibitor SY-3505 received ethical approval report for the pivotal phase III clinical trial [Google translation] (jrj.com) - "Capital Pharmaceutical Holdings...announced that the company recently received an approval report from the Ethics Committee of the Cancer Hospital of the Chinese Academy of Medical Sciences....The pivotal Phase III clinical trial of SY-3505 was officially launched."

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Phase Ib Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD

Metastases • New P1 trial • Oncology • Solid Tumor • LTK

Efficacy and safety of SY-3505, a third-generation ALK TKI, in ALK-positive advanced non-small cell lung cancer: Results from a phase I/II, multi-center study. (ASCO 2023) - P1/2 | "Patients received alectinib only or ≥2 prior ALK TKIs were recruited in phase II study and treated with SY-3505 at 600mg once daily. SY-3505 was well-tolerated and showed significant and durable clinical activity in ALK-positive NSCLC patients who received at least one prior 2nd-gen ALK TKI, demonstrating a potential new treatment option for these patient population. Pivotal clinical study will be performed in future. Clinical trial information: NCT05257512."

Clinical • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI (clinicaltrials.gov) - P2 | N=153 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD

Metastases • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Shouyao Holdings (688197.SH): The new indication of SY-3505 (CT-3505) has obtained the approval notice for drug clinical trials [Google translation] (Sina Corp) - "Shouyao Holdings...announced that on April 10, 2023, the company received the 'Notice of Drug Clinical Trial Approval' issued by the State Food and Drug Administration. The company's SY-3505...the application for clinical trials of capsules in patients with LTK gene fusion-positive advanced solid tumors was approved."

New trial • Oncology • Solid Tumor

Phase I/II Study of SY-3505 in Patients With ALK-positive Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD | Phase classification: P1 ➔ P1/2 | N=70 ➔ 150 | Trial completion date: Dec 2022 ➔ Aug 2024 | Trial primary completion date: Nov 2022 ➔ Apr 2024

Enrollment change • Metastases • Phase classification • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A Dose-Escalation/ Dose-Expansion Study of SY-3505 in Patients With ALK-positive Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD | Trial primary completion date: Jun 2022 ➔ Nov 2022

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase I, dose-escalation and dose-expansion study of SY-3505: A third-generation ALK TKI in Chinese ALK-positive advanced non-small cell lung cancer (ELCC 2022) - "Preliminary anti-tumor activity was also observed in patients who had received more than one first or second-generation ALK TKI. The dose-expansion phase of this study is ongoing."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A Dose-Escalation/ Dose-Expansion Study of SY-3505 in Patients With ALK-positive Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: Mar 2022 ➔ Jun 2022

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor