Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: QLS1103


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS1103 Dose Escalation and Expansion<br> | Drug: QLS1103<br>* Oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Area under the plasma concentration-time curve (AUC) of QLS1103 |  | Up to approximately 2 years | 
| Objective response rate (ORR) |  | Up to approximately 2 years | 
| Disease control rate (DCR) |  | Up to approximately 2 years | 
| Duration of response (DOR) |  | Up to approximately 2 years | 
| Progression free survival (PFS) |  | Up to approximately 2 years |