Testing ICP-723 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Rui Hua Xu, MD
• Email: xurh@sysucc.org.cn
• Phone: 13922296676

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.