Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

NCT05884801 | Unknown Phase 1

• 1 other identifier: QLS1103-101
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (1)

QLS1103 Dose Escalation and Expansion

EXPERIMENTAL

Drug: QLS1103

Interventions

QLS1103 DRUG

Oral dose

QLS1103 Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
• \. Aged ≥18 years old;
• \. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
• \. Failure of adequate standard treatment, or no effective standard treatment;
• \. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
• \. Life expectancy ≥12 weeks;

You may not qualify if:

• \. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
• \. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
• \. Subjects received major surgery within 4 weeks prior to the first dose;
• \. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>1 severity that is related to prior therapy;
• \. Cardiovascular and cerebrovascular diseases with clinical significance;
• \. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Shao

CONTACT

+8615221936606; qing1.shao@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: June 30, 2023
• Primary Completion: January 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-05

Locations

CN (1)