Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic Therapy

NCT07277972 | Not Yet Recruiting Phase 2

• 1 other identifier: E20251137
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to evaluate the improvement in Objective Response Rate (ORR) achieved with Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) in combination with Lenvatinib or Axitinib, in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have failed first-line systemic therapy.

Conditions

RCC, Renal Cell Cancer

Keywords

lparomlimab and Tuvonralimab Injection; Lenvatinib; Axitinib

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment.

  up to 12 month

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  up to 12 month

• Duration of Response

  up to 12 month

• Overall survival

  up to 36 month

• Adverse Events

  up to 36 month

Study Arms (1)

Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib

EXPERIMENTAL

Drug: Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib

Interventions

Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib DRUG

Iparomlimab and Tuvonralimab Injection: 5 mg/kg, iv, q3w, for a cumulative maximum treatment duration of 2 years; Lenvatinib: Starting dose of 12 mg, po, qd, q3w; or Axitinib: 5 mg, po, bid, q3w.

Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib

Eligibility Criteria

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

You may qualify if:

• Age at Diagnosis: ≥18 years.
• Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma.
• Disease progression or intolerance during or following first-line systemic therapy.
• ECOG Performance Status: 0-1.
• At least one measurable lesion as defined by RECIST v1.1.
• Life expectancy ≥12 weeks.
• Adequate bone marrow function: White blood cell count \> 4.0×10⁹/L, Hemoglobin \> 90 g/L, Platelet count \> 100×10⁹/L.
• Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × ULN; Aspartate aminotransferase and/or Alanine aminotransferase ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN.
• Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 × ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.
• The patient must provide signed informed consent and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as specified in the study protocol.
• Female subjects of childbearing potential must agree to use reliable contraceptive methods (e.g., condoms, prescribed oral contraceptives taken regularly) from screening until 1 year after the end of treatment.

You may not qualify if:

• Allergy to any component of macromolecular protein preparations; contraindications or hypersensitivity to any ingredient of Iparomlimab and Tuvonralimab Injection, Lenvatinib, or Axitinib.
• Major surgery within 28 days prior to the first dose (excluding diagnostic laparoscopy; local surgery for isolated lesions is acceptable).
• Positive Hepatitis B surface antigen (HBsAg) with HBV DNA \>1×10³ copies/mL, or positive anti-Hepatitis C virus (HCV) antibody.
• Positive anti-HIV antibody or a diagnosis of Acquired Immunodeficiency Syndrome (AIDS).
• Active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, asthma requiring bronchodilator therapy). Exceptions include type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
• Renal failure requiring hemodialysis or peritoneal dialysis.
• History of interstitial lung disease (ILD) or pneumonitis requiring oral or intravenous steroids within the past year; administration of Vancomycin within the past month.
• Chronic systemic glucocorticoid therapy (at a dose equivalent to ≥10 mg prednisone daily) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids are eligible.
• Uncontrolled cardiac disease, such as: 1) Heart failure, NYHA class ≥ II; 2) Unstable angina; 3) Myocardial infarction within the past year; 4) Supraventricular or ventricular arrhythmia requiring treatment or intervention.
• Thromboembolic events within 6 months prior to the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), or pulmonary embolism, etc.
• Known central nervous system metastases.
• Urinalysis indicating urine protein ≥ +++ and confirmed 24-hour urinary protein \>1.0 g.
• Pregnant or lactating women (a pregnancy test should be considered for sexually active women of childbearing potential).
• Prior or concurrent other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid.
• Active infection requiring systemic therapy within one week.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

lenvatinib; Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xin Yao

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Yao

CONTACT

+8613803000688; yaoxin@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): August 31, 2031
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share