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RecruitingNCT05884801Updated Aug 1, 2023

Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors

A Phase 1 interventional study of QLS1103 in Advanced Solid Tumor, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
148
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Advanced Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 148 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    QLS1103 Dose Escalation and Expansion

    Drug: QLS1103

Interventions

  • DrugQLS1103

    Oral dose

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What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Time frame: 21 Days (first cycle)

  2. Recommended dose for phase II (RP2D)

    Time frame: Up to 24 approximately months

  3. Adverse events(AEs) / Serious adverse events(SAEs)

    Time frame: Up to 24 approximately months

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of QLS1103

    Time frame: Up to approximately 2 years

  2. Time of maximum observed plasma concentration (Tmax) of QLS1103

    Time frame: Up to approximately 2 years

  3. Area under the plasma concentration-time curve (AUC) of QLS1103

    Time frame: Up to approximately 2 years

  4. Objective response rate (ORR)

    Time frame: Up to approximately 2 years

  5. Disease control rate (DCR)

    Time frame: Up to approximately 2 years

  6. Duration of response (DOR)

    Time frame: Up to approximately 2 years

  7. Progression free survival (PFS)

    Time frame: Up to approximately 2 years

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Study locations

1 of 1 sites recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510060, China
    • Huajun Chen, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05884801
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Jun 30, 2023
Primary completion
Jan 30, 2025 (estimated)
Completion
Jul 30, 2025 (estimated)
Last update
Aug 1, 2023

Study contacts

Qing Shao
Contact
qing1.shao@qilu-pharma.com
+8615221936606
Yilong Wu, MD
principal investigator · Guangdong Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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