AzTrials
AzTrials

RCC, Renal Cell CancerPhase 2NCT07277972

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

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib in people with RCC, Renal Cell Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
RCC, Renal Cell Cancer
What is being tested?
Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
15 Feb 2026to 31 Aug 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Administration of a live vaccine within 30 days prior to the first dose of Iparomlimab and Tuvonralimab Injection.
  • History of organ transplantation or hematopoietic stem cell transplantation.
  • Any other condition that, in the investigator's assessment, may compromise patient safety or compliance, such as severe concomitant illnesses (including psychiatric disorders) requiring prompt treatment, severely abnormal laboratory test results, or the presence of other psychological, familial, or sociogeographic factors posing high-risk.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xin Yao contact

+8613803000688

yaoxin@tjmuch.com

About this study

Official title: An Open-Label, Single-Arm, Multicenter, Phase II Clinical Study of 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

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.

Read the detailed description

This single-arm, multicenter clinical study aims 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.This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.

Being tested
Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib
Keywords
lparomlimab and Tuvonralimab Injection, Lenvatinib, Axitinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or AxitinibDrug

    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.

Study groups in NCT07277972
Study groupRoleWhat they receive
Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or AxitinibExperimentalNot described
Receives: Drug: Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 12 month

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from first dose of study treatment to the first documented PD per REClST 1.1 by investigator assessment, or death due to any cause, whichever occurred first.

    Measured: up to 12 month

  2. Duration of Response

    For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death，whichever occurs first.

    Measured: up to 12 month

  3. Overall survival

    OS was defined as the time from the first dose of study drug to death due to any cause.

    Measured: up to 36 month

  4. Adverse Events

    An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment.

    Measured: up to 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start15 Feb 2026 (estimated)
  3. Primary completion30 Nov 2029 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277972
Sponsor's protocol ID
E20251137
Status last verified
Nov 2025
First submitted
30 Nov 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib in people with RCC, Renal Cell Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xin Yao (+8613803000688, yaoxin@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: up to 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07277972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in