AL2846 / Advenchen, Sino Biopharm - LARVOL DELTA

A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma (clinicaltrials.gov) - P3 | N=144 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Efficacy and safety of multi-target tyrosine kinase inhibitor AL2846 combined with gemcitabine in pancreatic cancer. (PubMed, Invest New Drugs) - P1/2 | "Gemcitabine and Al2846 combination therapy exhibited tolerable safety, but there was no improvement in efficacy over standard treatment. Further evaluation of this approach is still needed."

Journal • Gastrointestinal Disorder • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Renal Disease • Solid Tumor • Thrombocytopenia

A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma (clinicaltrials.gov) - P3 | N=144 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P3 trial • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

AL2846 in patients (pts) with radioiodine-refractory differentiated thyroid carcinoma (RR-DTC) previously treated with tyrosine kinase inhibitors (TKI): Preliminary clinical results from the phase Ib study (ESMO 2024) - P1/2 | "AL2846 demonstrated a well-tolerated safety profile and a promising antitumor activity in previously TKI treated RR-DTC pts, which warrants further clinical evaluation."

Clinical • P1 data • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma • AXL • MET

Safety and Efficacy of AL2846 Combined with TQB2450 In NSCLC Patients with Previous PD-(L)1 Inhibitor Treated (NCT06116240) (IASLC-WCLC 2024) - P1 | "Conclusions : AL2846 combined PD-L1 inhibitor showed promising clinical activity in patients with locally advanced or metastatic NSCLC who previous treated with PD-(L)1 inhibitors. Based on the good efficacy and safety results of this study, the phase III study is currently being recruited."

Clinical • Cardiovascular • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • Squamous Cell Carcinoma

Six innovative Chinese biopharmaceutical drugs were unveiled at the World Lung Cancer Conference to empower patients with treatment [Google translation] (Sohu.com) - "Recently, the 2024 World Lung Cancer Conference (WCLC) announced the overall data of the various research results selected for this conference. A total of 16 latest research results and progress of Sino Biopharmaceutical's Class 1 innovative drugs anlotinib, Bevacizumab...alectinib, and the research products TQB2618 (TIM-3 inhibitor) and AL2846 (small molecule multi-target receptor tyrosine kinase inhibitor) were announced. Among them, 5 were oral reports (Mini oral) and 11 were poster presentations."

Clinical data

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. (PubMed, Cancer) - "Combined TQB2450 and AL2846 therapy exhibited a favorable safety profile in immunotherapy-refractory patients with advanced ESCC and HCC."

Journal • Metastases • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • AXL • FLT1 • FLT4 • KDR • KIT • MET

A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis (clinicaltrials.gov) - P1/2 | N=22 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=192 ➔ 22 | Trial completion date: Dec 2024 ➔ Feb 2024 | Recruiting ➔ Terminated; sponsor adjusts its research and development strategy

Enrollment change • Trial completion date • Trial termination • Brain Cancer • Fibrosis • Genetic Disorders • Neurofibromatosis • Neurofibrosarcoma • Oncology • Solid Tumor • NF1

A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=34 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=135 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P1 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy. (clinicaltrials.gov) - P3 | N=518 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P2 trial • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Clinical Study of AL2846 Capsule in the Treatment of Differentiated Thyroid Cancer (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis (clinicaltrials.gov) - P1/2; N=192; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Brain Cancer • Fibrosis • Genetic Disorders • Neurofibromatosis • Neurofibrosarcoma • Oncology • Solid Tumor • NF1

A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis (clinicaltrials.gov) - P1/2; N=192; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Brain Cancer • Fibrosis • Genetic Disorders • Neurofibromatosis • Neurofibrosarcoma • Oncology • Solid Tumor • NF1

[VIRTUAL] A phase Ⅰ open-label dose-escalation study of AL2846 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma. (ASCO 2021) - "The RP2D of AL2846 in combination with standard dose of gemcitabine were 90 and 120 mg QD continuously . The results demonstrated that AL2846 in combination with gemcitabine was well tolerated at doses up to 120 mg . Further clinical studies about the efficacy of AL2846 in pancreatic cancer are in progress."

Clinical • Combination therapy • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Leukopenia • Neutropenia • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Thrombocytopenia • AXL • FLT1

A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Apr 2020 ➔ Sep 2020

Clinical • Enrollment open • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET

A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Apr 2020 ➔ Jul 2020

Clinical • Enrollment open • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2; N=56; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P2 trial • ALK • EGFR

A Study of AL2846 on Tolerance and Pharmacokinetics (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Trial completion date: Dec 2018 ➔ Oct 2020; Trial primary completion date: Dec 2018 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date