Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

NCT07315854 | Recruiting Phase 2

• 1 other identifier: BFHHS20250012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 1.Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks.
2. 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. 3.Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity.
4. 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.

Conditions

Gastric Cancer (GC); Gastroesophageal Junction Cancer; Advanced Gastric Cancer; Metastatic Gastric Cancer

Keywords

Iparomlimab and Tuvonralimab; QL1706; Advanced or Metastatic Gastric Cancer; PD-1/CTLA-4 Bispecific Antibody; Immunotherapy; Chemotherapy Combination; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  From baseline until disease progression or loss of clinical benefit, assessed every 6 weeks for the first 24 weeks, then every 9 weeks, up to approximately 2 years.

Secondary Outcomes (6)

• Disease Control Rate (DCR)

  From baseline until disease progression or loss of clinical benefit, assessed every 6 weeks for the first 24 weeks, then every 9 weeks, up to approximately 2 years.

• Progression-Free Survival (PFS)

  From enrollment to the date of first documented progression or death, assessed up to approximately 2 years.

• Overall Survival (OS)

  From enrollment to the date of death, assessed up to approximately 2 years.

• 1-Year Progression-Free Survival (PFS) Rate

  At 1 year after enrollment.

• 1-Year Overall Survival (OS) Rate

  At 1 year after enrollment.

Study Arms (1)

QL1706 + SOX

EXPERIMENTAL

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.

Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: SOX Chemotherapy

Interventions

Iparomlimab and Tuvonralimab (QL1706) DRUG

Administered via intravenous (IV) infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.

QL1706 + SOX

SOX Chemotherapy DRUG

Oxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)\<1.25m2), 50mg (BSA≥1.25m2, and BAS\<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.

QL1706 + SOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Wei Deng, MD

CONTACT

+8613426136152; dengweiwei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 2, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)