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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.4 个研究点分布在 1 个国家目标入组 29 人2023年2月15日

适应症Advanced Lung Cancer Ovarian Cancer

干预措施AL2846 capsule

概览

阶段: 2 期
干预措施: AL2846 capsule
疾病 / 适应症: Advanced Lung Cancer
发起方: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
入组人数: 29
试验地点: 4
主要终点: Objective remission rate (ORR)
状态: 已完成
最后更新: 8个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2023年2月15日

结束日期

2025年8月20日

最后更新

8个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•Subjects with advanced lung cancer or ovarian cancer confirmed by histopathology or cytology;
•Age: 18\~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) score: 0-1;
•At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
•Normal function of main organs
•The serum Human Chorionic Gonadotropin (HCG) test of female patients of childbearing age must be negative within 7 days before study enrollment and must be non-lactating; The patient should agree to use contraception during the study period and within 6 months after the end of the study period;Male subjects should agree to use contraception during the study period and for 6 months after the study period ends;
•The patient voluntarily joined the study and signed the informed consent form, with good compliance.

排除标准

•Combined with the following diseases or medical history:
•Other malignant tumors have occurred or are present at the same time within\<3 years before the first administration.
•Inability to tolerate multiple factors affecting oral medication due to any reason;
•Common Terminology Criteria for Adverse Events (CTCAE) 5.0 \> grade 1 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss;
•Major surgical treatment or obvious traumatic injury was received within 4 weeks before the first administration;
•The presence of unhealed wounds, fractures, gastric and duodenal active ulcers, persistent positive fecal occult-blood, ulcerative colitis, or other conditions determined by investigators that may cause gastrointestinal bleeding or perforation;
•Arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months before the first medication;
•Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders;
•Subjects with any severe and/or uncontrollable disease；
•Tumor related symptoms and treatment:

研究组 & 干预措施

AL2846 capsule

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

干预措施: AL2846 capsule

结局指标

主要结局

Objective remission rate (ORR)

时间窗: From baseline up to 12 months.

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

Progression free survival (PFS)

时间窗: From baseline up to 12 months.

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

次要结局

Overall survival (OS)(From baseline to the death events, assessed up to 3 years.)
Adverse events (AEs) rate(From baseline to 28 days after the last dose or initiation of a new antineoplastic therapy (whichever comes first).)
Area under blood concentration-time curve (AUC)(Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.)
Disease control rate (DCR)(From baseline up to 12 months.)
Peak concentration (Cmax)(Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.)
Time to peak concentration (Tmax)(Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.)
Duration of remission (DOR)(From baseline up to 12 months.)
Clearance half life (t1/2)(Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days.)