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Not yet recruiting NCT06446388

Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

Phase II Interventional Advanced Solid Tumor

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: QLS31905, Oxaliplatin, Capecitabine, Gemcitabine.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors

Overview

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Interventions

  • Drug QLS31905
    Administered as an intravenous infusion.
  • Drug Oxaliplatin
    130 mg/m2, intravenous infusion, D1, up to 8 cycles.
  • Drug Capecitabine
    1000 mg/m2, oral, bid, D1-D14
  • Drug Gemcitabine
    1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
  • Drug Cisplatin
    25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
  • Drug QL1706
    5 mg/kg, intravenous infusion,D1
  • Drug Chemotherapy drug
    Standard chemotherapy recommended by guidelines.

Primary outcome measures

  • Objective response rate (ORR) [Time frame: Approximately 24 months]
Secondary outcome measures (12)
  • Safety assessed by Adverse Events (AEs) [Time frame: Approximately 24 months]
  • Safety assessed by incidence of serious adverse events (SAE) [Time frame: Approximately 24 months]
  • Number of participants with laboratory value abnormalities [Time frame: Approximately 24 months]
  • Duration of Response (DOR) [Time frame: Approximately 24 months]
  • Progression Free Survival(PFS) [Time frame: Approximately 24 months]
  • Overall Survival (OS) [Time frame: Approximately 24 months]
  • Maximum concentration (Cmax) [Time frame: Approximately 24 months]
  • Time of the maximum concentration (Tmax) [Time frame: Approximately 24 months]
  • Terminal elimination half-life (T1/2) [Time frame: Approximately 24 months]
  • Clearance (CL) [Time frame: Approximately 24 months]
  • Apparent volume of distribution during the terminal phase (Vz) [Time frame: Approximately 24 months]
  • Number of anti-drug antibody (ADA) Positive Participants [Time frame: Approximately 24 months]

Eligibility criteria

Inclusion criteria

  • Subjects voluntarily participate in the study and sign the informed consent form;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • Expected survival time ≥ 3 months;
  • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
  • No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
  • Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
  • At least one measurable lesion per RECIST v1.1;
  • Patients with adequate cardiac, liver, renal function, etc.

Exclusion criteria

  • History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
  • Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
  • Known central nervous system metastases;
  • Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
  • Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.

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
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06446388 · QLS31905-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗