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Renal Cell Carcinoma (RCC)Phase 2NCT07488572

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

A Phase 2 study testing Yivoximab in people with Renal Cell Carcinoma (RCC) and Metastatic Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Yivoximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Nov 2025to 1 Jun 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 join

  • 1. Non-clear cell histology or mixed histology with non-clear cell component >25%.
  • 2. Prior treatment with PD-1/PD-L1 inhibitors, VEGF/VEGFR inhibitors, or other immune checkpoint inhibitors.
  • 3. Active autoimmune disease requiring systemic immunosuppressive therapy. 4. Uncontrolled hypertension (systolic BP >150 mmHg or diastolic BP >100 mmHg despite medication).
  • 5. Significant cardiovascular disease including unstable angina, myocardial infarction, or congestive heart failure (NYHA Class III-IV) within 6 months.
  • 6. 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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.

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.

Read more

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.

Being tested
Yivoximab
Medical subject headings
Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma

What participants receive

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

  • YivoximabDrug

    Yivoximab (AK112) is a human IgG1κ dual-target monoclonal antibody that simultaneously binds to PD-1 and VEGF. It is administered intravenously at a dose of 20 mg/kg every 3 weeks as monotherapy. The drug is designed to enhance anti-tumor immune response by blocking immune checkpoint inhibition while inhibiting angiogenesis. This intervention is being evaluated as first-line treatment for metastatic clear cell renal cell carcinoma.

Study groups in NCT07488572
Study groupRoleWhat they receive
Yivoximab Monotherapy ArmExperimentalThis 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.
Receives: Drug: Yivoximab

What is being measured

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

  1. Objective Response Rate (ORR)

    The objective response rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria, assessed by independent radiology review. ORR will be evaluated at baseline and every 6 weeks thereafter until disease progression or withdrawal from the study. The primary endpoint will be analyzed in the intent-to-treat (ITT) population.

    Measured: From study start to data cutoff date (approximately 24 months)

Secondary outcomes (6)

  1. Disease Control Rate (DCR)

    The disease control rate (DCR) is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for at least 6 weeks, based on RECIST v1.1 criteria. DCR will be assessed during follow-up visits and reported at the final analysis.

    Measured: From study start to data cutoff date (approximately 24 months)

  2. Overall Survival (OS)

    Overall survival (OS) is defined as the time from the first dose of Yivoximab to death from any cause. OS will be estimated using the Kaplan-Meier method and reported with 95% confidence intervals. Follow-up will continue until the end of the study or until the patient is lost to follow-up.

    Measured: From first dose of study drug to death from any cause, up to 36 months

  3. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    TEAEs will be collected and graded according to CTCAE v5.0. Includes all AEs occurring from first dose until 30 days after last dose.

    Measured: During treatment and up to 30 days after last dose

  4. Changes in Laboratory Parameters

    Hematology, chemistry, and urinalysis values will be monitored throughout the study. Abnormalities will be graded per CTCAE v5.0.

    Measured: Baseline, every cycle, and at end of treatment; up to 24 months

  5. Vital Signs Monitoring

    Blood pressure, heart rate, temperature, and respiratory rate will be measured at each visit.

    Measured: At screening, baseline, every cycle, and at end of treatment; up to 24 months

  6. Concomitant Medication Use

    All concomitant medications will be recorded from screening through end of study.

    Measured: From screening until end of study (approximately 24 months)

Timeline

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

  1. First posted23 Mar 2026
  2. Study start1 Nov 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2027 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07488572
Sponsor's protocol ID
2025-FXY-506
Status last verified
Mar 2026
First submitted
19 Jan 2026
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
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 Yivoximab in people with Renal Cell Carcinoma (RCC) and Metastatic Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 16 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From study start to data cutoff date (approximately 24 months)). 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 NCT07488572.

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 23 Mar 2026.

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