NCT04685226 A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
| NCT ID | NCT04685226 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2020-09-27 |
| Primary Completion | 2028-01-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 310 participants in total. It began in 2020-09-27 with a primary completion date of 2028-01-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04685226 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04685226 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04685226 currently recruiting?
Yes, NCT04685226 is actively recruiting participants. Contact the research team at xurh@sysucc.org.cn for enrollment information.
Where is the NCT04685226 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT04685226 clinical trial?
NCT04685226 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The trial plans to enroll 310 participants.