Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neurofibrosarcoma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Fibrosarcoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Neurofibromatosis

Neurofibromatosis Type 1

Malignant Peripheral Nerve Sheath Tumor

Soft Tissue Sarcoma

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

During the dose escalation phase, patients enrolled in the group will first receive a single fasting administration（AL2846 capsules 120-150mg，oral）. The observation period is 3 days. If dose-limited toxity (DLT) does not occur, they will continue to receive multiple consecutive fasting administrations (120mg-150mg，once a day，oral ),every 28 days as a treatment cycle.

During the dose expansion phase, patients will receive multiple consecutive fasting administrations (AL2846 capsules，120mg-150mg, oral ), every 28 days as a treatment cycle.

AL2846 is a multi-target receptor tyrosine kinase inhibitor.

AL2846 capsules

AL2846 is a multi-target receptor tyrosine kinase inhibitor. The purpose of this study is to evaluate the safety and efficacy of AL2846 capsules in Chinese patients with type I neurofibromatosis (NF1) (neurofibromas and malignant peripheral nerve sheath tumors).

A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis

Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis (Neurofibromatosis and Malignant Peripheral Nerve Sheath Tumors)

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)

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

recommended dose of Phase II clinical trial

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

The time when the participants first achieved complete or partial remission to disease progression.

Rate of patients with PFS reaching one year among all patients

From date of first administration of test drug until the date of death from any cause

Self-report of pain in target tumor and other parts of body

Questionnaires about the quality of life (including mental state, appetite state, sleep, etc.)

Self-report on the severity of tumor pain, overall pain status, and tumor-related problems other than pain (vision, hearing, mobility, hearing, appearance, etc.)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Gemcitabine

Antimetabolites

AL2846 capsules combined with Gemzar injection,28 days as a treatment cycle

AL2846 is a multi -target receptor tyrosine kinase inhibitor.

Gemzar

This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies.

A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer

A Phase I/IIa Clinical Trial AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer.

One or more unacceptable toxic reactions that appear after administration cause the dose or extend the dose cycle that cannot continue to increase the dose or extend the dose

If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial to Evaluate the Safety and Efficacy of AL2846 Capsules in Chinese Patients With Type I Neurofibromatosis	NCT05011019	Neurofibromatos...	AL2846 capsules	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer	NCT06278493	Pancreatic Canc...	AL2846 capsules Gemzar	18 Years - 70 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for al2846 capsules