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

NCT07046780 | Not Yet Recruiting

• 1 other identifier: NCC5416
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.

Conditions

Solid Tumor Cancer; Metastatic Solid Tumors; Locally Advanced

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥3 irAEs

  2 years

Secondary Outcomes (3)

• Incidence of adverse events

  2 years

• Incidence of treatment-related adverse events

  2 years

• Incidence of immune-related adverse events

  2 years

Other Outcomes (5)

• Objective response rate

  2 years

• Overall Survival

  2 years

• Progression-Free Survival

  2 years

Study Arms (1)

Observation group

Patients treated with Iparomilimab and Tuvonralimab in the real world

Drug: Observation arm

Interventions

Observation arm DRUG

To observe the efficacy and safety of Iparomilimab and Tuvonralimab in the treatment of patients with solid tumors in the real world

Observation group

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• \) 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;
• \) ECOG performance status 0-2;
• \) ≥1 measurable lesion per RECIST v1.1 ;
• \) Adequate organ function meeting ALL criteria below:
• 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
• 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
• Urinalysis :
• Urine protein \<2+ (dipstick) If protein ≥2+, 24h urinary protein ≤1.0 g
• Coagulation (without anticoagulants):
• PT/APTT/INR ≤1.5×ULN
• \) Life expectancy ≥12 weeks;
• \) Contraception : Females of childbearing potential or males with partners of childbearing potential must use effective contraception during treatment and for 6 months post-treatment;
• \) Signed informed consent and protocol compliance.

You may not qualify if:

• \) Tumor-Related Conditions
• Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);
• Other malignancies within past 5 years, excluding:
• Cured basal/squamous cell skin cancer Localized low-risk prostate cancer Cervical/breast carcinoma in situ
• Severe bone lesions from metastatic disease, including:
• Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;
• Uncontrolled effusions requiring recurrent drainage (pleural/pericardial/ascites), per investigator assessment.
• \) Prior Anti-tumor Therapy
• Prior systemic therapy with CTLA-4 inhibitors or other ICIs;
• Any anti-tumor treatment within 4 weeks before first dose, including:
• Surgery/chemotherapy/palliative radiotherapy to non-target lesions/hormonal/targeted/biologic/immunotherapy;
• Treatment-related toxicities not recovered to CTCAE grade ≤1 (exceptions: alopecia/platinum-induced neuropathy ≤ grade 2).
• \) Comorbidities \& History
• Arterial thromboembolism within 6 months (MI/unstable angina/stroke/TIA);
• Symptomatic heart failure (NYHA class III-IV), unstable angina, or uncontrolled arrhythmia;

Sponsors & Collaborators

• PENG YUAN: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Central Study Contacts

Xue Wang

CONTACT

86-010-87787242; wxyxyuki@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 2, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)