Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Amino Acids

Tyrosine Kinase Inhibitors

Iodine

Cadexomer iodine

Tyrosine

AL2846 capsules monotherapy, 28 days as a treatment cycle.

AL2846 is a multi-target tyrosine kinase inhibitor

AL2846 capsule

Wei Fu, Master

Feng Shi, Doctor

Zhijun Chen, Master

Zhijun Chen

Zhi-yong Deng, Master

Zhi-yong Deng

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.

Clinical Study of AL2846 Capsule in the Treatment of Differentiated Thyroid Cancer

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

ORR is defined as the percentage of participants with complete remission (CR) and partial remission (PR) based on investigator records.

PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.

DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease.

The time from the start of the first evaluation of the tumor as CR or PR to the first assessment as PD or death from any cause.

Time from the first administration to death due to any cause.

Adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

orally administer AL2846 capsules monotherapy, 28 days as a treatment cycle.

AL2846 is a multi-target tyrosine kinase inhibitor.

Hui Wang, Doctor

Peng Zhang, Doctor

Jie Meng, Doctor

Xingxiang Xu, Doctor

This is a multi-cohort, randomized, open, multicenter Phase II study to evaluate the efficacy and safety of AL2846 capsules in patients with advanced lung cancer and ovarian cancer. Objective response rate (ORR) and progression-free survival (PFS) are the primary endpoints.

Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer

A Multi-cohort, Randomized, Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AL2846 Capsules in Treated Subjects With Advanced Solid Tumors

ORR is defined as the percentage of subjects in complete remission (CR), partial remission (PR), and disease stability (SD).

Percentage of subjects achieving complete response (CR) and partial response (PR).

The time from the first evaluation as CR or PR to the first evaluation as PD or death from any cause.

Time from the first administration to death from any cause.

Occurrence of all adverse events, regardless of whether there was a causal relation with the studied drug.

Time to reach peak plasma drug concentration after dose.

The time it takes for the drug concentration in the body to drop by half

After administration, the area under the curve is obtained using the blood drug concentration as the ordinate and time as the abscissa.

Antineoplastic Agents

Hematinics

Vitamins

Antibodies

Antibodies, Monoclonal

Pemetrexed

Cisplatin

Immunoglobulins

Folic Acid Antagonists

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle.

TQB2450 injection, 21 days as a treatment cycle. AL2846 capsule, 21 days as a treatment cycle. Pemetrexed disodium for injection, 21 days as a treatment cycle. Cisplatin injection, 21 days as a treatment cycle.

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).

TQB2450 injection

AL2846 is a multi-targeted tyrosine kinase receptor inhibitor

Pemetrexed disodium is a multi-target antifolate antineoplastic drug.

Pemetrexed disodium for injection

Cisplatin injection

This is a Phase Ib clinical trial to evaluate the safety and efficacy of TQB2450 injection combined with AL2846 capsules in patients with advanced solid tumors.

A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors

A Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors

Proportion of subjects achieving complete and partial response

The proportion of subjects with adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators

The severity of adverse events (AE), severe adverse events (SAE) and abnormal laboratory examination indicators assessed by Common Terminology Criteria For Adverse Events (CTCAE) 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of AL2846 Capsule in the Treatment of Differentiated Thyroid Cancer	NCT05745363	Differentiated ...	AL2846 capsule	18 Years - 80 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer	NCT05815862	Advanced Lung C... Ovarian Cancer	AL2846 capsule	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors	NCT06116240	Solid Tumor	TQB2450 injecti... AL2846 capsule Pemetrexed diso... Cisplatin injec...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors	NCT06116240	Solid Tumor	TQB2450 injecti... AL2846 capsule Pemetrexed diso... Cisplatin injec...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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