Evaluating ICP-033 for patients with advanced solid tumors
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
This study is testing a new tablet called ICP-033 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. Industry-sponsored |
| Locations | 1 site (Sichuan, Chengdu) |
| Trial ID | NCT05367232 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the safety, tolerability, and pharmacokinetics of ICP-033 tablets in patients with advanced solid tumors. It is a Phase 1 interventional trial that focuses on dose finding and assessing preliminary anti-tumor activity. Eligible participants will have histologically confirmed locally advanced unresectable or metastatic solid tumors and at least one measurable lesion. The study will monitor participants for adverse effects and treatment responses to establish the optimal dosing regimen.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors who have a good performance status and measurable disease.
Not a fit: Patients with unstable CNS tumors, significant ECG abnormalities, or those who are pregnant or breastfeeding 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 not widely tested, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors; 3. At least one measurable lesion according to RECIST 1.1. Exclusion Criteria: 1. Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug. 2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases. 3. Patients who have active or history of interstitial lung disease or noninfectious pneumonia. 4. Patients with QTc \> 450 ms in males and \> 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator. 5. Patient with the Medication history and surgical history as stated in the protocol 6. Those who are unsuitable for blood collection or contraindicated for blood collection. 7. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.
Where this trial is running
Sichuan, Chengdu
- West China Hospital of Sichuan University — Sichuan, Chengdu, China (Recruiting)
Study contacts
- Principal investigator: Feng Bi — West China Hospital
- Study coordinator: Feng Bi
- Email: bifeng@medmail.com
- Phone: +86 028-85423203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.