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Not yet recruitingNCT06394713Updated May 1, 2024

A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

A Phase 1/2 interventional study of QLF31907 and Irinotecan in Advanced Malignant Neoplasm, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-01.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.

02

Conditions studied

  • Advanced Malignant Neoplasm

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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 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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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. subjects voluntarily participated and signed a written informed consent form;
  2. age ≥18 years, male or female;
  3. ECOG PS 0-1;
  4. histopathologically diagnosed advanced malignant tumors;
  5. at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
  6. adequate organ function;

Exclusion criteria

Exclusion Criteria:

  1. previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
  2. received anti-tumor therapy within 4 weeks prior to the first study treatment;
  3. history of autoimmune disease;
  4. history of other active malignancies within 3 years prior to the first treatment;
  5. history of serous cardiovascular events;
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    QLF31907 in combination with Irinotecan

    Drug: QLF31907 · Drug: Irinotecan

  • Experimental
    QLF31907 in combination with Docetaxel

    Drug: QLF31907 · Drug: Docetaxel

Interventions

  • DrugQLF31907

    intravenous administration, once every 3 weeks

  • DrugIrinotecan

    intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks

  • DrugDocetaxel

    intravenous administration, 75mg/m2, d1, every 3 weeks

06

What researchers measure

Primary outcomes

  1. phase Ib: Dose-limiting toxicity(DLT)

    The DLT of QLF31907 combination therapy will be determined

    Time frame: 28 days

  2. phase2: objective response rate(ORR)

    the ORR of QLF31907 combinaton therapy will be determined

    Time frame: up to 2 years

Secondary outcomes

  1. adverse events (AEs) of QLF31907 combination therapy

    to evaluate the severity, incidence and causality of adverse events (AEs)

    Time frame: up to 2 years

  2. area under the concentration-time curve (AUC) of QLF31907

    the area under the concentration-time curve (AUC) of QLF31907 will be determined

    Time frame: up to 2 years

  3. Immunogenicity of QLF31907

    the anti-drug antibody(ADA) against QLF31907 will be determined

    Time frame: up to 2 years

  4. overall survival(OS)

    the OS of QLF31907 combination therapy will be determined

    Time frame: up to 2 years

  5. maximum plasma concentration (Cmax) of QLF31907

    the maximum plasma concentration (Cmax) of QLF31907 will be determined

    Time frame: up to 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06394713
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 1, 2024
Start date
Jun 15, 2024 (estimated)
Primary completion
Jun 15, 2025 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
May 1, 2024

Study contacts

Lin Shen
Contact
doctorshenlin@sina.cn
010-88196561

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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