Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: QLS1103

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qing Shao; Phone Number: +8615221936606; Email: qing1.shao@qilu-pharma.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Huajun Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS1103 Dose Escalation and Expansion	Drug: QLS1103; Oral dose

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yilong Wu, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QLS1103-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No