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NCT Number: NCT06394713

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

QLF31907

Drug

intravenous administration, once every 3 weeks

Irinotecan

Drug

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

docetaxel

Drug

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

Primary outcomes

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

    Time frame: 28 days

    The DLT of QLF31907 combination therapy will be determined

  2. phase2: objective response rate(ORR)

    Time frame: up to 2 years

    the ORR of QLF31907 combinaton therapy will be determined

Secondary outcomes

  1. adverse events (AEs) of QLF31907 combination therapy

    Time frame: up to 2 years

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

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

    Time frame: up to 2 years

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

  3. Immunogenicity of QLF31907

    Time frame: up to 2 years

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

  4. overall survival(OS)

    Time frame: up to 2 years

    the OS of QLF31907 combination therapy will be determined

  5. maximum plasma concentration (Cmax) of QLF31907

    Time frame: up to 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Shen

CONTACT

[email protected]

010-88196561

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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