A Study of ICP-033 in Patients With Advanced Solid Tumors

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Description

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.

Study Overview

Start Date
February 25, 2022
Completion Date
December 1, 2025
Enrollment
60
Date Posted
May 10, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
West China Hospital of Sichuan University
Sichuan, Chengdu 610041, China

Eligibility

Minimum Age (years)
18
Maximum Age (years)
75
Eligibility Criteria
Inclusion Criteria:

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 Criteria:

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.

Study Contact Info

Study Contact Name
Feng Bi
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05367232