^
    3ms
    A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=38, Recruiting, 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
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    LTK (Leukocyte Receptor Tyrosine Kinase)
    |
    ficonalkib (SY-3505)
    3ms
    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, Shouyao Holdings (Beijing) Co. LTD
    New P3 trial • Metastases
    |
    Xalkori (crizotinib) • ficonalkib (SY-3505)
    3ms
    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)
    Ficonalkib (SY-3505) was well tolerated, with favorable safety profiles and promising efficacy in patients resistant to prior 2-gen ALK TKI.
    Journal • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive
    |
    ficonalkib (SY-3505)
    8ms
    A Study of SY-3505 in Patients With Advanced LTK Fusion-Positive Solid Tumors (clinicaltrials.gov)
    P1, N=38, Recruiting, Shouyao Holdings (Beijing) Co. LTD
    New P1 trial • Metastases
    |
    LTK (Leukocyte Receptor Tyrosine Kinase)
    |
    ficonalkib (SY-3505)
    12ms
    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, Shouyao Holdings (Beijing) Co. LTD
    New P2 trial • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK fusion
    |
    ficonalkib (SY-3505)
    1year
    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)
    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 • P1/2 data • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive
    |
    Alecensa (alectinib) • ficonalkib (SY-3505)
    1year
    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, 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
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive
    |
    ficonalkib (SY-3505)