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Not yet recruiting NCT06394713

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

Phase I / Phase II Interventional Advanced Malignant Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLF31907, Irinotecan, Docetaxel.
Who it may be relevant to
Registry conditions: Advanced Malignant Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug QLF31907
    intravenous administration, once every 3 weeks
  • Drug Irinotecan
    intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
  • Drug Docetaxel
    intravenous administration, 75mg/m2, d1, every 3 weeks

Primary outcome measures

  • phase Ib: Dose-limiting toxicity(DLT) [Time frame: 28 days]
  • phase2: objective response rate(ORR) [Time frame: up to 2 years]
Secondary outcome measures (5)
  • adverse events (AEs) of QLF31907 combination therapy [Time frame: up to 2 years]
  • area under the concentration-time curve (AUC) of QLF31907 [Time frame: up to 2 years]
  • Immunogenicity of QLF31907 [Time frame: up to 2 years]
  • overall survival(OS) [Time frame: up to 2 years]
  • maximum plasma concentration (Cmax) of QLF31907 [Time frame: up to 2 years]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06394713 · QLF31907-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗