A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsules Combined With TQB2450 Injection Compared With Docetaxel Injection in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed With Immunotherapy.

To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.

Start Date08 Jun 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20231281 / RecruitingPhase 3

评价 AL2846 胶囊联合 TQB2450 注射液对比多西他赛注射液在经免疫治疗失败的晚期非小细胞肺癌患者中有效性和安全性的多中心、随机、双盲、平行对照 III 期临床试验。

[Translation] This is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial to evaluate the efficacy and safety of AL2846 capsules combined with TQB2450 injection versus docetaxel injection in patients with advanced non-small cell lung cancer who have failed immunotherapy.

主要目的：与多西他赛注射液对照，评价 AL2846 胶囊联合 TQB2450 注射液治疗经免疫治疗失败的晚期非小细胞肺癌患者的有效性。次要目的：与多西他赛注射液对照，评价 AL2846 胶囊联合 TQB2450 注射液治疗经免疫治疗失败的晚期非小细胞肺癌患者的安全性在经免疫治疗失败的晚期非小细胞肺癌受试者中评价 TQB2450 注射液的免疫原性。

[Translation]

Primary objective: To evaluate the efficacy of AL2846 capsule combined with TQB2450 injection in patients with advanced non-small cell lung cancer who have failed immunotherapy, compared with docetaxel injection. Secondary objective: To evaluate the safety of AL2846 capsule combined with TQB2450 injection in patients with advanced non-small cell lung cancer who have failed immunotherapy, compared with docetaxel injection. To evaluate the immunogenicity of TQB2450 injection in subjects with advanced non-small cell lung cancer who have failed immunotherapy.

Start Date05 Jun 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT05745363 / RecruitingPhase 1/2

Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsule in Iodine-resistant Differentiated Thyroid Cancer With Previous TKI Treatment Failure

This is a Phase Ib clinical trial to evaluate the efficacy and safety of AL2846 capsule in iodine-refractory differentiated thyroid cancer that has failed previous TKI treatment. The trial is planned to enroll 20 subjects. The trial is a single-arm, multi-center, open label clinical study. Objective response rate (ORR) is the primary endpoint.

Start Date24 Feb 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Vilzemetkib

100 Translational Medicine associated with Vilzemetkib

100 Patents (Medical) associated with Vilzemetkib

Literatures (Medical) associated with Vilzemetkib

15 Sep 2024·Cancer

Anti‐PD‐L1 antibody TQB2450 combined with tyrosine kinase receptor inhibitor AL2846 for immunotherapy‐refractory advanced hepatocellular carcinoma and esophageal squamous cell carcinoma: A prospective phase 1b cohort study

Article

Author: Bai, Yuxian ; Wang, Zhiyu ; Li, Danyang ; Chen, Ye ; Deng, Ting ; Lu, Wei ; Ning, Tao ; Hu, Bin ; Ba, Yi

AbstractBackgroundEffective systemic therapy remains limited for advanced esophageal squamous cell carcinoma (ESCC) and hepatocellular carcinoma (HCC), particularly after prior failed treatment with immune checkpoint inhibitors (ICIs). Theoretically, a combination of tyrosine kinase inhibitors (TKIs) with ICIs may restore immunotherapy sensitivity.MethodsIn this phase 1b study, patients received AL2846, an antiangiogenic TKI with multiple targets (c‐MET, VEGFR1, c‐KIT, Axl, RET, KDR, and VEGFR3), in combination with an anti–PD‐L1 antibody (TQB2450) until disease progression, intolerable toxicity, death, or discontinuation for any cause. The primary end points included overall response rate (ORR) and safety, with secondary end points encompassing progression‐free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response.ResultsBetween November 2021 and September 2022, 18 patients with ESCC and 15 patients with HCC, whose ORR was 11.1% (95% confidence interval [CI], 3.1%–32.8%) and 0%, respectively, were enrolled. Adverse events (AEs) of any grade and treatment‐related AEs were documented in 32 patients (97.0%) and 31 patients (93.9%), respectively. Grade 3 or higher AEs were observed in 10 patients (30.3%), with vomiting (6.1%) and infectious pneumonia (9.1%) being the most prevalent. Median PFS and OS values were 3.22 months (95% CI, 1.35–5.68 months) and 5.98 months (95% CI, 3.71–8.87 months), respectively, in patients with ESCC, and 5.55 months (95% CI, 2.66 months to not evaluable [NE]) and 16.72 months (95% CI, 4.86 months to NE), respectively, in patients with HCC. The DCRs were 66.7% (95% CI, 43.75%–83.72%) in patients with ESCC and 73.3% (95% CI, 48.05%–89.10%) in patients with HCC.ConclusionsCombined TQB2450 and AL2846 therapy exhibited a favorable safety profile in immunotherapy‐refractory patients with advanced ESCC and HCC.

100 Deals associated with Vilzemetkib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	05 Jun 2023
Neurofibromatosis 1	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	07 Sep 2021
Neurofibrosarcoma	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	07 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 2	CN	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	03 Feb 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	03 Feb 2023
Neoplasms	Phase 2	CN	Advenchen Laboratories LLC	30 Jan 2022
Pancreatic Cancer	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Aug 2018
Advanced Lung Non-Small Cell Carcinoma	Preclinical	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	24 Sep 2020
Bone metastases	Preclinical	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	24 Sep 2020
Advanced Colorectal Adenocarcinoma	Preclinical	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	20 Jul 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05745363 (ESMO2024) Manual	Phase 1	Refractory Differentiated Thyroid Gland Carcinoma	28	AL2846	(ijhxayxnrp) = ybzcqhgsas yioocqolrq (pvbdpzitjk ) View more	Positive	16 Sep 2024
NCT06116240 (WCLC2024) Manual	Phase 1	Non-Small Cell Lung Cancer Second line	44	TQB2450+AL2846	(gktxwjtvhd) = neluxtxmbv fzrzqfoauc (shsydhasny ) View more	Positive	09 Sep 2024
CTR20201021 (ASCO2021)	Phase 1	Locally Advanced Pancreatic Adenocarcinoma	15	AL2846 + Gemcitabine	(rrwvjarfhs) = msrzabsszs zgwwacsllx (kpmvwhdeln ) View more	-	28 May 2021

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