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RecruitingNCT05823285Updated Apr 21, 2023

A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients

A Phase 1 interventional study of QLS31903 in Advanced Solid Tumors, 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 2023-04-21.

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

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 196 studies on the registry; 118 are open to participants now.

Browse Qilu Pharmaceutical Co., Ltd. studies →

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

04

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

  • 18 years or older, 40kg or heavier
  • Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ )
  • Standard treatment failed or standard treatment intolerant, no standard treatment
  • Adequate hepatic, hematologic, and renal function

Key Exclusion Criteria:

  • Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions
  • Other clinical trial within 4 weeks prior to the first QLS31903 administration
  • Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
  • Prior treatment targeted on GPC3
  • HBsAg/HBcAb positive and HBV-DNA>10,000 copy/mL;HCV-Ab positive and HCV-RNA>1,000 copy/mL
  • CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    QLS31903

    0.01μg/kg-2.16 μg/kg QLS31903 for injection

    Drug: QLS31903

Interventions

  • DrugQLS31903

    0.01μg/kg-2.16 μg/kg QLS31903 for injection

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose（MTD）for Phase 1a

    The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.

    Time frame: 21days or 14 days after the first target dose(whichever is longer）

  2. Recommended phase 2 dose(RP2D) for Phase 1a

    The RP2D is defined as the dose level chosen by Safety Monitoring Committee(SMC)

    Time frame: Duration of study, approximately 24 months

  3. Objective Response Rate (ORR) for phase 1b

    ORR is the percentage of patients with best response of CR and PR

    Time frame: From fist administration of QLS31903 to disease progression，death，loss to follow up,withdrawal of consent,initiation of a new anticancer therapy,study completion/closure,whichever came first, assessed up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Fudan Zhongshan Hospital
    Shanghai, Shanghai Municipality 200000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05823285
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 21, 2023
Start date
Mar 22, 2023
Primary completion
Jun 15, 2025 (estimated)
Completion
Jun 15, 2027 (estimated)
Last update
Apr 21, 2023

Study contacts

Yan Chen, PhD
Contact
yan12.chen@qilu-pharma.com
8617843558626
Xiaoyan Kang, PhD
study chair · Qilu Pharmaceutical Co., Ltd.

Oversight

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

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