A Prospective, Single-Center, Exploratory Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy in the Treatment of Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer. The main questions it aims to answer are: 1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will: 1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks. 2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles. 3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity. 4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures.

• Age 18-80 years, gender is not limited.

• Patients with locally advanced unresectable, recurrent unresectable, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) confirmed by imaging and other examinations, and histopathologically confirmed as adenocarcinoma.

• Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0/1+, or IHC 2+ with FISH/ISH negative.

• No prior systemic therapy for advanced or metastatic GC/GEJC (including anti-HER-2 therapy). Patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC/GEJC are eligible if the time to first recurrence or disease progression is greater than 6 months from the end of the last treatment. Prior use of anti-tumor Traditional Chinese Medicine preparations is allowed but must be discontinued at least 2 weeks before enrollment.

• ECOG performance status score of 0 or 1.

• Must have at least one measurable lesion according to RECIST v1.1 definitions.

• All acute toxicities caused by prior anti-tumor therapy or surgery must have resolved to Grade 0-1 (according to NCI CTCAE v5.0) or to the level specified in the inclusion/exclusion criteria. Alopecia, fatigue, and hearing loss, or other toxicities considered by the investigator not to pose a safety risk to the subject, are excluded.

• Adequate organ function (laboratory tests within 7 days prior to treatment):

‣ Hematology (No blood transfusion, G-CSF use, or drug correction within 14 days prior to screening):

⁃ White blood cell count (WBC) ≥ 3,000/mm³ (3.0 × 10⁹/L);

⁃ Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L);

⁃ Platelet count (PLT) ≥ 100,000/mm³ (100 × 10⁹/L);

⁃ Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L).

• Biochemistry (No albumin transfusion within 14 days prior to screening):

‣ Albumin ≥ 3.0 g/dL (30 g/L);

⁃ Creatinine ≤ 1.5 × Upper Limit of Normal (ULN) or Creatinine Clearance ≥ 50 ml/min (calculated using the Cockcroft-Gault formula);

⁃ Total Bilirubin (BIL) ≤ 1.5 × ULN;

⁃ Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 × ULN; for patients with liver metastases, ≤ 5 × ULN.

• Coagulation: International Normalized Ratio (INR) ≤ 1.5, Prothrombin Time (PT), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.

• Urine: Urine protein \< 2+; if urine protein is ≥ 2+, 24-hour urine protein quantification must be ≤ 1g.

• Life expectancy ≥ 3 months.

• Women of childbearing potential must undergo a serum or urine pregnancy test within 7 days before starting treatment, with a negative result, and must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Wei Deng, MD
dengweiwei@126.com
+8613426136152
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 32
Treatments
Experimental: QL1706 + SOX
Participants will receive induction therapy with Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (Oxaliplatin and S-1) for 6 cycles (every 3 weeks). This is followed by maintenance therapy with QL1706 and S-1 until disease progression, intolerable toxicity, or other discontinuation criteria are met.
Sponsors
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov