Testing ICP-723 for advanced solid tumors

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

This study is testing a new drug called ICP-723 to see how safe it is and how well it works for people with advanced solid tumors that can't be removed by surgery.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 24 sites (Hefei, Anhui and 23 other locations)
• Trial ID: NCT04685226 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of ICP-723 in patients with advanced solid tumors. It is a multicenter, nonrandomized, open-label study that includes both adult and adolescent cohorts. Participants must have histopathologically confirmed unresectable locally advanced or metastatic solid tumors, with at least one measurable lesion. The trial aims to gather data on how well ICP-723 is tolerated and its effects on tumor progression.

Who should consider this trial

Good fit: Ideal candidates are adults and adolescents aged 12 years and older with unresectable locally advanced or metastatic solid tumors.

Not a fit: Patients with other active malignancies within the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this approach is being tested in this trial, similar studies have shown promise in targeting advanced solid tumors with novel therapies.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 23 other locations

• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Medical Center of the Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Cancer Hospital Affiliated to Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
• Sun Yat-Sen University Cancer Center — Guangdong, Guangzhou, China (Recruiting)
• Shijiazhuang People's Hospital — Shijiazhuang, Hebei, China (Recruiting)
• Cancer Hospital Affiliated to Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College,Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer hospital — Changsha, Hunan, China (Recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The first affiliated hospital Zhejiang university school of medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Rui Hua Xu, MD

Conditions Solid Tumors