A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors

NCT04685226 | Recruiting Phase 1

• 1 other identifier: ICP-CL-00501
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 24

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

• MTD

  To determine maximum tolerated dose (MTD)

  Up to 2 Months

Secondary Outcomes (2)

• Cmax

  Up to 1 month

• ORR

  Up to 2 months

Study Arms (1)

ICP-723

EXPERIMENTAL

ICP-723

Drug: ICP-723

Interventions

ICP-723 DRUG

ICP-723 is a white, round, uncoated table

ICP-723

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors..
• Age:
• Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years \< 18 years.
• 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.
• Adult cohort: ECOG PS score of 0-1;
• Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) PS score \> 60.
• Life expectancy \> 3 months.
• 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.
• Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (24)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100081, China

RECRUITING

The First Medical Center of the Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100081, China

RECRUITING

Cancer Hospital Affiliated to Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangdong, Guangzhou, 510060, China

RECRUITING

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Hunan Cancer hospital

Changsha, Hunan, 410000, China

RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, ,310000, China

RECRUITING

The first affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Central Study Contacts

Rui Hua Xu, MD

CONTACT

13922296676; xurh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: September 27, 2020
• Primary Completion (Estimated): January 25, 2028
• Study Completion (Estimated): February 25, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (24)