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Status unknownNCT05278832Updated Mar 14, 2022

A Study of QLS31905 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of QLS31905 in Advanced Solid Tumors, sponsored by Qilu Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.

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

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2021, registered Feb 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
104
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.

02

Conditions studied

  • Advanced Solid Tumors

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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 104 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.

04

Who can participate

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

Inclusion criteria

  1. Written informed consent.
  2. ≥18 years.
  3. Female or male.
  4. ECOG performance status score 0 or 1.
  5. Histologically or cytologically confirmed diagnosis of advanced solid tumors.
  6. Adequate haematological, hepatic and renal function.

Exclusion criteria

Exclusion Criteria:

  1. Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.
  2. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
  3. Patients with a history of monoclonal antibody allergic reaction.
  4. Known human immunodeficiency virus infection or known symptomatic hepatitis.
05

Study design

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

Study arms

  • Experimental
    QLS31905

    QLS31905 injection

    Drug: QLS31905

Interventions

  • DrugQLS31905

    QLS31905 injection

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicities(DLTs)

    Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905

    Time frame: 2 years

  2. Maximum tolerated Dose(MTD)

    To evaluate the safety and tolerability of QLS31905

    Time frame: 2 years

Secondary outcomes

  1. Progression-free Survival (PFS)

    Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.

    Time frame: 2 years

  2. Objective response rate (ORR)

    Objective Response Rate (ORR) is the percentage of CR+PR

    Time frame: 2 years

  3. Disease control rate (DCR)

    Disease control Rate (DCR) is the percentage of CR+PR+SD

    Time frame: 2 years

  4. adverse events (AE)

    To evaluate the safety and tolerability of QLS31905

    Time frame: 2 years

  5. Cmax

    Maximum concentration (Cmax) of the drug after administration

    Time frame: 2 years

  6. AUC

    The area under the curve (AUC) of serum concentration of the drug after the administration

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05278832
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 14, 2022
Start date
Oct 25, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 14, 2022

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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