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

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.

Start Date30 May 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

NCT06254599 / Not yet recruitingPhase 3

A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer

A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.

Start Date01 May 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

CTR20240005 / RecruitingPhase 3

一项评估CT-3505胶囊对比克唑替尼胶囊在ALK阳性非小细胞肺癌患者中的有效性和安全性的随机、对照、多中心III期临床试验

[Translation] A randomized, controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of CT-3505 capsules compared with crizotinib capsules in patients with ALK-positive non-small cell lung cancer

主要目的：评估CT-3505胶囊对比克唑替尼胶囊在初治的ALK阳性NSCLC患者中的有效性次要目的：评估CT-3505胶囊在初治的ALK阳性NSCLC患者中的安全性

[Translation]

Primary objective: To evaluate the efficacy of CT-3505 capsules compared with crizotinib capsules in patients with ALK-positive NSCLC who are undergoing treatment for the first time. Secondary objective: To evaluate the safety of CT-3505 capsules in patients with ALK-positive NSCLC who are undergoing treatment for the first time.

Start Date22 Mar 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

100 Clinical Results associated with Ficonalkib

100 Translational Medicine associated with Ficonalkib

100 Patents (Medical) associated with Ficonalkib

Literatures (Medical) associated with Ficonalkib

01 Jun 2024·Journal of Thoracic Oncology

Ficonalkib (SY-3505) in Advanced ALK-Positive NSCLC: A Multicenter, Open-Label, Single-Arm, Phase 1/2 Study

Article

Author: Gong, Caifeng ; Mei, Qi ; Dong, Xiaorong ; Jiang, Liyan ; Wang, Pingli ; Wang, Ke ; Li, Xingya ; Li, Yongsheng ; Liu, Baogang ; Hu, Xingsheng ; Sun, Yinghui ; Meng, Xiangjiao ; Yang, Runxiang ; Wang, Huijuan ; Luo, Yongzhong ; Zhang, Shucai ; Shi, Yuankai ; Yang, Limin

INTRODUCTIONTreatment options for second-generation (2^nd-gen) ALK tyrosine kinase inhibitor (TKI)-resistant patients are limited. We evaluated the safety, pharmacokinetics, and efficacy of ficonalkib (SY-3505), a third-generation (3^rd-gen) ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer.METHODSThis first-in-human, phase 1/2 study (Chinese Clinical Trial Registry identifier: ChiCTR1900025619; ClinicalTrials.gov identifier: NCT05257512) had two parts. Phase 1 included a dose-escalation phase (25-800 mg quaque die [QD]) and a dose-expansion phase (500 mg QD or 600 mg QD). Phase 2 enrolled patients treated at recommended phase 2 dose. Primary end points were safety in phase 1 and objective response rate (ORR) in phase 2.RESULTSBetween April 21, 2020, and August 31, 2023, a total of 127 patients with advanced ALK-positive non-small cell lung cancer were enrolled, with 62 in phase 1. Ficonalkib was well absorbed and tolerated, with one dose-limited toxicity event occurring at 800 mg QD. Treatment-related adverse events occurred in 85.5% of patients, with 19.4% experienced greater than or equal to grade 3 events. The ORR was 38.3% (23 of 60, 95% confidence interval [CI]: 26.1%-51.8%) in phase 1, and 600 mg QD was established as recommended phase 2 dose. In phase 2, a total of 65 patients received ficonalkib at 600 mg QD. In total, 88 patients received ficonalkib at 600 mg QD in phase 1/2, and all had received prior 2^nd-gen ALK TKI treatment. Furthermore, 90.9% of the patients experienced treatment-related adverse events and 14.8% experienced greater than or equal to grade 3 events. The ORR in efficacy-assessable patients who received ficonalkib at 600 mg QD was 47.5% (38 of 80, 95% CI: 36.2%-59.0%), with an intracranial ORR of 37.5% (12 of 32, 95% CI: 21.1%-56.3%) in these patients with measurable brain lesions at baseline.CONCLUSIONSFiconalkib (SY-3505) was well tolerated, with favorable safety profiles and promising efficacy in patients resistant to prior 2^nd-gen ALK TKI.

100 Deals associated with Ficonalkib

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	Phase 3	CN	Shouyao Holdings (Beijing) Co. Ltd.	22 Mar 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Shouyao Holdings (Beijing) Co. Ltd.	30 Jun 2023
LTK-positive Solid Tumors	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	30 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05257512 \| ChiCTR1900025619 (Pubmed) Manual	Phase 1/2	ALK positive Non-Small Cell Lung Cancer	127	Ficonalkib (SY-3505) 25-800 mg QD	(orqoqxemcm) = nmeyrcmaro vaqhzhaola (gbzviznsgw, 26.1 - 51.8)	Positive	01 Jan 2024
				Ficonalkib (SY-3505) 600 mg QD	(orqoqxemcm) = ucvbbdisdx vaqhzhaola (gbzviznsgw, 36.2 - 59.0)
NCT05257512 (ASCO2023) Manual	Phase 1/2	ALK positive Non-Small Cell Lung Cancer ALK Expression	82	CT-3505	(dmdfmuqczb) = vgmbxvgtxj xfqxjnjxru (zszsaabvvx, 24.0 - 45.5) View more	Positive	31 May 2023
				CT-3505 (patients received SY-3505 at 600mg once daily)	(dmdfmuqczb) = btynorgvmn xfqxjnjxru (zszsaabvvx, 24.5 - 53.6) View more

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