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Enrolling by invitationPhase 2

Testing Yivoximab alone in kidney cancer that spread when TKI drugs are not tolerated

Tests Yivoximab alone in adults with metastatic clear cell kidney cancer.

Key facts

Who runs it
Sun Yat-sen University
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Safety and Efficacy of Yiwoxidan Anti (AK112) Monotherapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Are Intolerant to TKI Treatment: a Prospective, Single Arm, Phase II Clinical Study
Status
Enrolling by invitation
Phase
Phase 2
People taking part
60 people, planned
Started
1 Nov 2025
Expected to end
1 Jun 2027
Type of study
Interventional
Treatments tested
  • Yivoximab
Record updated
23 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with clear cell kidney cancer that has spread and who have had no earlier drug treatment for it. Everyone gets AK112 (Yivoximab).

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Clear cell renal cell carcinoma that has spread (metastatic), with at least one lesion that can be measured by RECIST v1.1.
Earlier treatment
No earlier systemic treatment for advanced or metastatic clear cell kidney cancer. Earlier PD-1/PD-L1 inhibitors, VEGF/VEGFR inhibitors or other immune checkpoint inhibitors are not allowed.

Main reasons for not taking part

  • Non-clear cell kidney cancer, or mixed type with more than 25% non-clear cell part
  • Active autoimmune disease that needs treatment to lower the immune system
  • Uncontrolled high blood pressure, or serious heart disease within 6 months
  • Brain or spinal cord metastases with symptoms
  • Active infection such as HBV, HCV, HIV or tuberculosis; pregnancy or breastfeeding

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Age between 18 and 75 years, inclusive
  • Histologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC)
  • Metastatic disease with at least one measurable lesion according to RECIST v1.1 criteria
  • No prior systemic therapy for advanced or metastatic ccRCC
  • ECOG Performance Status of 0 or 1
  • Expected survival ≥12 weeks
  • Adequate organ function:; Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥1.5 × 10⁹/L; Platelets ≥100 × 10⁹/L; Total bilirubin ≤1.5 × ULN; AST/ALT ≤2.5 × ULN (≤5.0 × ULN if liver metastases present); Serum creatinine ≤1.5 × ULN or eGFR ≥60 mL/min/1.73m²; INR ≤1.5 or aPTT within normal limits
  • Female patients of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study and for 12 weeks after last dose
  • Willing and able to provide written informed consent

Who cannot take part

  • 1. Non-clear cell histology or mixed histology with non-clear cell component >25%; Prior treatment with PD-1/PD-L1 inhibitors, VEGF/VEGFR inhibitors, or other immune checkpoint inhibitors; Active autoimmune disease requiring systemic immunosuppressive therapy. 4. Uncontrolled hypertension (systolic BP >150 mmHg or diastolic BP >100 mmHg despite medication); Significant cardiovascular disease including unstable angina, myocardial infarction, or congestive heart failure (NYHA Class III-IV) within 6 months; Symptomatic central nervous system metastases or spinal cord compression. 7. Active infection including HBV, HCV, HIV, or active tuberculosis. 8. Known hypersensitivity to AK112 or its excipients. 9. Pregnancy or breastfeeding. 10. Any condition that may interfere with the interpretation of study results or pose an undue risk to the participant, as determined by the investigator

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part

About the trial

What the trial wants to find out

This study is testing a new medicine called AK112 (Yivoximab) for people with advanced kidney cancer that has spread to other parts of the body (metastatic clear cell renal cell carcinoma). AK112 is a special kind of drug called a dual-target antibody that works in two ways: it helps the immune system fight cancer and blocks blood vessels that feed the tumor.

Read full original descriptionShow less

The goal of this study is to see how well AK112 works as a first-line treatment (before any other treatment) and how safe it is. We will look at how many patients' tumors shrink or stop growing, how long they live without their disease getting worse, and whether they have side effects.

This is a Phase II, single-arm, open-label study, meaning all participants will receive AK112, and everyone involved knows what treatment is being given. The study will take place at multiple hospitals across China and will include about 60 patients aged 18 to 75 years who have not received prior systemic treatment for advanced kidney cancer.

Participants will receive AK112 through an IV infusion every three weeks until the cancer progresses or side effects become too severe. They will have regular check-ups, including blood tests, imaging scans (like CT or MRI), and physical exams to monitor their health and response to treatment.

The study is expected to start in November 2023 and end in June 2027. Participation is voluntary, and all medical care related to the study will be provided at no cost. Participants may also be covered by clinical trial insurance in case of unexpected harm.

We hope this study will help find a better treatment option for people with advanced kidney cancer.

The group in the trial

  • Yivoximab Monotherapy ArmTreatment being tested

    This arm includes patients with metastatic clear cell renal cell carcinoma who receive Yivoximab (AK112) as first-line monotherapy. The drug is administered intravenously at a dose of 20 mg/kg every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. All participants are followed for efficacy and safety outcomes, including objective response rate, progression-free survival, overall survival, and adverse events.

    Treatment: Yivoximab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Safety and Efficacy of Yiwoxidan Anti (AK112) Monotherapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Are Intolerant to TKI Treatment: a Prospective, Single Arm, Phase II Clinical Study
Plain-language title
Testing Yivoximab alone in kidney cancer that spread when TKI drugs are not toleratedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07488572, who can take part
Record updated
23 March 2026