Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

NCT ID: NCT05884801

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-07-30

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS1103 Dose Escalation and Expansion

Group Type: EXPERIMENTAL

QLS1103

Intervention Type: DRUG

Oral dose

Interventions

QLS1103

Oral dose

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yilong Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qing Shao

Role: CONTACT

qing1.shao@qilu-pharma.com

+8615221936606

Facility Contacts

Huajun Chen, MD

Role: primary

Other Identifiers

QLS1103-101

Identifier Type: -

Identifier Source: org_study_id