Status:
RECRUITING
A Study of ICP-033 in Patients With Advanced Solid Tumors
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Patients With Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-033 Tablets in Patients with Advanced Solid Tumors.
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
- At least one measurable lesion according to RECIST 1.1.
Exclusion
- 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.
- Patients with unstable primary central nervous system (CNS) tumors or CNS metastases.
- Patients who have active or history of interstitial lung disease or noninfectious pneumonia.
- 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.
- Patient with the Medication history and surgical history as stated in the protocol
- Those who are unsuitable for blood collection or contraindicated for blood collection.
- Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05367232
Start Date
February 25 2022
End Date
December 1 2025
Last Update
February 7 2024
Active Locations (1)
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1
West China Hospital of Sichuan University
Sichuan, Chengdu, China, 610041