Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884801
• Other study ID #: QLS1103-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 30, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Qing Shao
• Phone: +8615221936606
• Email: qing1.shao[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: July 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• QLS1103
Oral dose

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)		21 Days (first cycle)
Primary	Recommended dose for phase II (RP2D)		Up to 24 approximately months
Primary	Adverse events(AEs) / Serious adverse events(SAEs)		Up to 24 approximately months
Secondary	Maximum observed plasma concentration (Cmax) of QLS1103		Up to approximately 2 years
Secondary	Time of maximum observed plasma concentration (Tmax) of QLS1103		Up to approximately 2 years
Secondary	Area under the plasma concentration-time curve (AUC) of QLS1103		Up to approximately 2 years
Secondary	Objective response rate (ORR)		Up to approximately 2 years
Secondary	Disease control rate (DCR)		Up to approximately 2 years
Secondary	Duration of response (DOR)		Up to approximately 2 years
Secondary	Progression free survival (PFS)		Up to approximately 2 years