Solid Tumors Clinical Trial
Official title:
A Multicenter, Nonrandomized, Open-Label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Solid Tumors
A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors
Status | Recruiting |
Enrollment | 310 |
Est. completion date | February 2028 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: 1. Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors.. 2. Age: Adult Cohort: Age = 18 years; Adolescent cohort: 12 = years < 18 years. 3. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria. 4. Adult cohort: ECOG PS score of 0-1; 5. Adolescent cohort: Karnofsky (age = 16 years) or Lansky (age < 16 years) PS score > 60. 6. Life expectancy > 3 months. 7. Female patients or male patients of childbearing potential, who agree to use medically acceptable effective methods of birth control throughout the study up to 12 weeks after the last dose of the study treatment. 8. Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule. Exclusion Criteria: 1. Any other active malignancy within 5 years prior to the first dose of the study drug. 2. Prior anti-cancer treatment within 28 days prior to the first dose. 3. Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug. 4. A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation. 5. Other situations that, in the investigator's opinion, would make the subject unsuitable for participation in the study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Cancer Hospital | Beijing | Beijing |
China | The First Medical Center of the Chinese People's Liberation Army General Hospital | Beijing | Beijing |
China | Hunan Cancer hospital | Changsha | Hunan |
China | Sun Yat-Sen University Cancer Center | Guangdong | Guangzhou |
China | Cancer Hospital Affiliated to Guangzhou Medical University | Guangzhou | Guangdong |
China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
China | Cancer Hospital Affiliated to Harbin Medical University | Ha'erbin | Heilongjiang |
China | The first affiliated hospital Zhejiang university school of medicine | Hangzhou | Zhejiang |
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | Affiliated Cancer Hospital of Shandong First Medical University | Jinan | Shandong |
China | Yunnan Cancer Hospital | Kunming | Yunnan |
China | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan |
China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
China | Jiangsu Provincial People's Hospital | Nanjing | Jiangsu |
China | Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | Shijiazhuang People's Hospital | Shijiazhuang | Hebei |
China | Shanxi Cancer Hospital | Taiyuan | Shanxi |
China | Union Hospital, Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei |
China | Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu |
China | Henan Cancer Hospital | Zhengzhou | Henan |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
China | The Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Beijing InnoCare Pharma Tech Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | To evaluate the safety and tolerability of ICP-723 at different doses in the treatment of advanced solid tumors; | Up to 12 months | |
Primary | MTD | To determine maximum tolerated dose (MTD) | Up to 2 Months | |
Secondary | Cmax | To preliminarily obtain pharmacokinetic (PK) data of ICP-723 in the treatment of advanced solid tumors include the peak plasma concentration (Cmax) | Up to 1 month | |
Secondary | ORR | Objective Response Rate | Up to 2 months |
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