Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: QLS1103

• Registration Number: NCT05884801
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-01
• Study Start: 2023-06-30
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Primary Completion: 2025-01-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
QLS1103 Dose Escalation and Expansion	QLS1103	-

Primary Outcome Measures

Name	Time	Method
Recommended dose for phase II (RP2D)	Up to 24 approximately months
Adverse events(AEs) / Serious adverse events(SAEs)	Up to 24 approximately months
Maximum tolerated dose (MTD)	21 Days (first cycle)

Secondary Outcome Measures

Name	Time	Method
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
Duration of response (DOR)	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
Progression free survival (PFS)	Up to approximately 2 years

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China