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Trial Title:
Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors
NCT ID:
NCT05884801
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLS1103
Description:
Oral dose
Arm group label:
QLS1103 Dose Escalation and Expansion
Summary:
This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate
the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in
subjects with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Subjects must voluntarily agree to participate in the trial and sign a written
informed consent form;
-
2. Aged ≥18 years old;
-
3. Histologically or cytologically confirmed advanced or recurrent or metastatic
solid tumor;
-
4. Failure of adequate standard treatment, or no effective standard treatment;
-
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
-
6. Life expectancy ≥12 weeks;
Exclusion Criteria:
-
1. Subjects received systemic anticancer therapy within 4 weeks prior to the first
dose;
-
2. Subjects received experimental medication or therapy within 4 weeks prior to
the first dose;
-
3. Subjects received major surgery within 4 weeks prior to the first dose;
-
4. Persistent toxicity of National Cancer Institute Common Terminology Criteria
for Adverse Events (NCI CTCAE) Grade >1 severity that is related to prior
therapy;
-
5. Cardiovascular and cerebrovascular diseases with clinical significance;
-
6. Active gastrointestinal disease or other conditions that significantly
interfere with drug absorption.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Huajun Chen, MD
Start date:
June 30, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884801
