Advanced Solid Tumor
Conditions
Brief 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.
Interventions
DRUGQLS1103
Oral dose
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) | 21 Days (first cycle) |
| Recommended dose for phase II (RP2D) | Up to 24 approximately months |
| Adverse events(AEs) / Serious adverse events(SAEs) | Up to 24 approximately months |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) of QLS1103 | Up to approximately 2 years |
| Objective response rate (ORR) | Up to approximately 2 years |
| Progression free survival (PFS) | Up to approximately 2 years |
| Duration of response (DOR) | Up to approximately 2 years |
| Disease control rate (DCR) | Up to approximately 2 years |
| Maximum observed plasma concentration (Cmax) of QLS1103 | Up to approximately 2 years |
| Time of maximum observed plasma concentration (Tmax) of QLS1103 | Up to approximately 2 years |
Countries
China
Contacts
Primary ContactQing Shao
Outcome results
None listed