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Starting soon Phase 2

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

NCT06446388 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-06-30
Last updated
2024-06-06

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

QLS31905 →Oxaliplatin →Capecitabine →Gemcitabine →Cisplatin →QL1706 →Chemotherapy drug

QLS31905: Administered as an intravenous infusion.

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

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

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

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

QL1706: 5 mg/kg, intravenous infusion,D1

Chemotherapy drug: Standard chemotherapy recommended by guidelines.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective response rate (ORR) — 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)

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06446388 on ClinicalTrials.gov ↗ ← All trials in China