^
9ms
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)
9ms
New P3 trial • Metastases
|
Xalkori (crizotinib) • ficonalkib (SY-3505)
10ms
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
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ALK (Anaplastic lymphoma kinase)
|
ALK positive
|
ficonalkib (SY-3505)
1year
New P1 trial • Metastases
|
LTK (Leukocyte Receptor Tyrosine Kinase)
|
ficonalkib (SY-3505)
over1year
New P2 trial • Metastases
|
ALK (Anaplastic lymphoma kinase)
|
ALK positive • ALK fusion
|
ficonalkib (SY-3505)
over1year
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)
over1year
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)