A Multicenter, Prospective, Non-Interventional Real-World Study of Iparomlimab and Tuvonralimab Injection (QL1706) in the Treatment of Locally Advanced or Metastatic Solid Tumors

Launched by PENG YUAN · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how safe and effective a new treatment called QL1706—which combines two medicines, Iparomlimab and Tuvonralimab—is for people with advanced solid tumors. These tumors are cancers that have either spread from their original location or grown very large and cannot be removed by surgery. The study will observe about 90 patients across multiple centers to see how well this treatment works in real-life medical settings, without changing usual care.

People who might join this trial are adults with certain types of solid tumors, such as lung, breast, gastrointestinal cancers, or soft tissue sarcoma, whose cancer has progressed despite previous treatments. They need to be in fairly good health otherwise and have at least one tumor that can be measured to track response. Participants will receive the QL1706 treatment, and the study team will monitor their health and how their cancer responds. It’s important to know that this trial is not yet recruiting and has specific criteria to ensure safety, including no recent other cancer treatments or serious health problems like uncontrolled infections or heart issues. If you or a loved one fits these criteria, this study might offer a chance to try a promising new therapy while being closely monitored by doctors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;
• • 2) ECOG performance status 0-2;
• • 3) ≥1 measurable lesion per RECIST v1.1 ;
• * 4) Adequate organ function meeting ALL criteria below:
• 1. Hematology (without transfusion/G-CSF support within 7 days):
• • Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets ≥100×10⁹/L Hemoglobin ≥90 g/L
• 2. Biochemistry :
• • Total bilirubin (TBIL) ≤2×ULN ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present) Serum creatinine (Cr) ≤1.5×ULN Albumin ≥28 g/L
• 3. Urinalysis :
• • Urine protein \<2+ (dipstick) If protein ≥2+, 24h urinary protein ≤1.0 g
• 4. Coagulation (without anticoagulants):
• • PT/APTT/INR ≤1.5×ULN
• • 5) Life expectancy ≥12 weeks;
• • 6) Contraception : Females of childbearing potential or males with partners of childbearing potential must use effective contraception during treatment and for 6 months post-treatment;
• • 7) Signed informed consent and protocol compliance.
• Exclusion Criteria:
• • 1) Tumor-Related Conditions
• • 1. Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);
• 2. Other malignancies within past 5 years, excluding:
• • Cured basal/squamous cell skin cancer Localized low-risk prostate cancer Cervical/breast carcinoma in situ
• 3. Severe bone lesions from metastatic disease, including:
• • Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;
• • 4. Uncontrolled effusions requiring recurrent drainage (pleural/pericardial/ascites), per investigator assessment.
• • 2) Prior Anti-tumor Therapy
• • 1. Prior systemic therapy with CTLA-4 inhibitors or other ICIs;
• 2. Any anti-tumor treatment within 4 weeks before first dose, including:
• • Surgery/chemotherapy/palliative radiotherapy to non-target lesions/hormonal/targeted/biologic/immunotherapy;
• • 3. Treatment-related toxicities not recovered to CTCAE grade ≤1 (exceptions: alopecia/platinum-induced neuropathy ≤ grade 2).
• • 3) Comorbidities \& History
• • 1. Arterial thromboembolism within 6 months (MI/unstable angina/stroke/TIA);
• • 2. Symptomatic heart failure (NYHA class III-IV), unstable angina, or uncontrolled arrhythmia;
• • 3. Severe pulmonary disease : ILD/COPD/symptomatic bronchospasm;
• 4. Active uncontrolled infection (≥CTCAE grade 2), including:
• • HIV Active HBV (DNA ≥500 IU/mL) HCV (Ab+ with detectable RNA) HBV/HCV co-infection;
• • 5. History of neurologic/psychiatric disorders;
• • 6. Recent or current substance abuse;
• • 7. Prior allogeneic organ/hematopoietic stem cell transplantation.
• • 4) Hypersensitivity to study drug or its excipients.
• • 5) Active autoimmune disease requiring treatment or history within 2 years. Exceptions: Vitiligo/alopecia/psoriasis not needing systemic therapy Hypothyroidism managed only with hormone replacement Type 1 diabetes controlled solely with insulin.
• • 6) Pregnant/lactating women;
• • 7) Any uncontrolled systemic disease increasing study risk (per investigator);
• • 8) Other unsuitable conditions determined by investigator.