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NCT Number: NCT06446388

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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

QLS31905

Drug

Administered as an intravenous infusion.

Oxaliplatin

Drug

130 mg/m2, intravenous infusion, D1, up to 8 cycles.

Capecitabine

Drug

1000 mg/m2, oral, bid, D1-D14

Gemcitabine

Drug

1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.

Cisplatin

Drug

25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.

QL1706

Drug

5 mg/kg, intravenous infusion,D1

Chemotherapy drug

Drug

Standard chemotherapy recommended by guidelines.

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Approximately 24 months

    ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)

Secondary outcomes

  1. Safety assessed by Adverse Events (AEs)

    Time frame: Approximately 24 months

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.

  2. Safety assessed by incidence of serious adverse events (SAE)

    Time frame: Approximately 24 months

    Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.

  3. Number of participants with laboratory value abnormalities

    Time frame: Approximately 24 months

    Number of participants with potentially clinically significant laboratory values.

  4. Duration of Response (DOR)

    Time frame: Approximately 24 months

    DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first).

  5. Progression Free Survival(PFS)

    Time frame: Approximately 24 months

    PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first).

  6. Overall Survival (OS)

    Time frame: Approximately 24 months

    OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.

  7. Maximum concentration (Cmax)

    Time frame: Approximately 24 months

    Cmax will be derived from the PK serum samples collected.

  8. Time of the maximum concentration (Tmax)

    Time frame: Approximately 24 months

    Tmax will be derived from the PK serum samples collected.

  9. Terminal elimination half-life (T1/2)

    Time frame: Approximately 24 months

    T1/2 will be derived from the PK serum samples collected.

  10. Clearance (CL)

    Time frame: Approximately 24 months

    CL will be derived from the PK serum samples collected.

  11. Apparent volume of distribution during the terminal phase (Vz)

    Time frame: Approximately 24 months

    Vz will be derived from the PK serum samples collected.

  12. Number of anti-drug antibody (ADA) Positive Participants

    Time frame: Approximately 24 months

    Immunogenicity will be measured by the number of participants that are ADA positive.

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
Jun 6, 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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