A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
- Registration Number
- NCT04685226
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors
- Detailed Description
Solid Tumors
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 310
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Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors..
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Age:
Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years < 18 years.
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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.
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Adult cohort: ECOG PS score of 0-1;
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Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) PS score > 60.
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Life expectancy > 3 months.
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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.
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Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule.
- Any other active malignancy within 5 years prior to the first dose of the study drug.
- Prior anti-cancer treatment within 28 days prior to the first dose.
- Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
- A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-723 ICP-723 ICP-723
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Up to 12 months To evaluate the safety and tolerability of ICP-723 at different doses in the treatment of advanced solid tumors;
MTD Up to 2 Months To determine maximum tolerated dose (MTD)
- Secondary Outcome Measures
Name Time Method Cmax Up to 1 month To preliminarily obtain pharmacokinetic (PK) data of ICP-723 in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)
ORR Up to 2 months Objective Response Rate
Trial Locations
- Locations (24)
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Cancer Hospital Affiliated to Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangdong, Guangzhou, China
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Medical Center of the Chinese People's Liberation Army General Hospital
🇨🇳Beijing, Beijing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Cancer Hospital Affiliated to Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
🇨🇳Zhuhai, Guangdong, China
Shijiazhuang People's Hospital
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Hunan Cancer hospital
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, 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
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Affiliated Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The first affiliated hospital Zhejiang university school of medicine
🇨🇳Hangzhou, Zhejiang, China