Status:
RECRUITING
A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2028
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04685226
Start Date
September 27 2020
End Date
February 25 2028
Last Update
September 2 2025
Active Locations (24)
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1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100081
3
The First Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100081
4
Cancer Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China, 510000