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Renal Cell CarcinomaPhase 2NCT05256472

A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma

A Phase 2 study testing AK104 and axitinib in people with Renal Cell Carcinoma and First-line Treatment, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II, open-label trial to evaluate the efficacy and safety of AK104 monotherapy or AK104 in combination with axitinib as a first-line treatment for advanced/metastatic renal cell carcinoma (RCC). There are two parts in this trial. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Cell Carcinoma, First-line Treatment
What is being tested?
AK104 and axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
6 Jul 2023to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Provide written informed consent/assent for the trial.
  • Be≥18 and ≤ 75 years of age on day of signing informed consent, no matter male or female.
  • Have Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to first dosing of AK104.
  • Have estimated life expectancy of at least 3 months.
  • Have histologically or cytologically confirmed diagnosis of RCC with advanced/metastatic disease (i.e., Stage IV RCC per American Joint Committee on Cancer) with clear cell or non-clear cell component (part 1) or solely clear cell component (part 2).
  • Have received no prior systemic therapy for advanced RCC . Note: Prior neoadjuvant/adjuvant therapies are acceptable if disease progression occurred > 12 months after last dosage of neoadjuvant/adjuvant treatment.
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  • Have measurable disease per RECIST 1.1 as assessed by the investigator /site radiologist. (brain metastases were excluded).
  • Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
  • Adequate organ function as determined by:
  • Hematology: i. absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1,500/mm3); ii. platelets ≥ 100 × 10^9/L (100,000/mm3); iii. hemoglobin ≥ 90 g/L.
  • Renal: i. calculated creatinine clearance * (CrCl) ≥ 50 mL/min; * CrCl will be calculated using the Cockcroft-Gault formula CrCL (mL/min) = {(140-age) × body weight (kg) × F }/(SCr (mg/dL) × 72) Where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. ii. urine protein < 2 + or 24-hour urine protein must be < 2.0 g.
  • Hepatic: i. serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN, ≤ 3.0 × ULN with liver metastasis; iii. serum albumin (ALB) ≥ 28 g/L.
  • Coagulation function: i. international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • Cardiac Function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.

Who cannot join

  • Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded.
  • Has had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, IL-2R, GITR，CTLA-4，CD40, CD137.
  • Has received prior therapy with VEGF/VEGFR or mTOR targeting agents.
  • Has received radiotherapy within 14 days prior to start of study treatment and has not recovered adequately from any toxicity and/or complications from prior radiotherapy.
  • Has newly diagnosed brain metastases or known symptomatic brain metastases requiring steroids. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to receiving first dose of trial treatment, have discontinued corticosteroid treatment for these metastases for at least 3 days and are neurologically stable.
  • Had major surgery 4 weeks or major radiation therapy 2 weeks prior to receiving first dose of trial treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 48 hours prior to receiving first dose of trial treatment.
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  • Has active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Subjects with diabetes type I, vitiligo, psoriasis, hypo-or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to receiving first dose of trial treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Has an active tuberculosis and syphilitic infection.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibodies).
  • Has known active Hepatitis B (e.g., Hepatitis B surface antigen [HBsAg] reactive and HBV-DNA>200 IU/ml) or Hepatitis C virus (e.g., HCV RNA [qualitative] is detected).
  • Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mmHg.
  • Has active bleeding disorder or other history of significant bleeding episodes within 30 days of screening.
  • Has been pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment (30 days for axitinib, whichever occurs last).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase II Trial of Cadonilimab (AK104) Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma (RCC)

This is a Phase II, open-label trial to evaluate the efficacy and safety of AK104 monotherapy or AK104 in combination with axitinib as a first-line treatment for advanced/metastatic renal cell carcinoma (RCC). There are two parts in this trial. In part 1 of this study, subjects with unresectable advanced clear cell or non-clear cell renal cell carcinoma (ccRCC or nccRCC) who had not received systemic therapy for advanced disease will be enrolled to randomly received three different dosage of AK104 monotherapy. In part 2 of this study, subjects with unresectable advanced clear cell renal cell carcinoma (ccRCC) who had not received systemic therapy for advanced disease will be enrolled to receive AK104 plus Axitinib. All subjects will receive treatment until disease progression, development of unacceptable toxicity, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators.

Being tested
AK104, axitinib
Keywords
AK104, 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.

  • AK104Drug

    anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)

  • axitinibDrug

    an oral, small molecule, TKI selective for VEGFRs 1, 2 and 3; 5mg bid orally

Study groups in NCT05256472
Study groupRoleWhat they receive
AK104 monotherapy cohort (Part 1)ExperimentalSubjects in this cohort will randomly receive three different dosage of AK104 monotherapy administered intravenously.
Receives: Drug: AK104
combination treatment cohort (Part 2)ExperimentalSubjects in this cohort will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally.
Receives: Drug: AK104; Drug: axitinib

What is being measured

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

  1. ORR per RECIST v1.1 as assessed by investigators

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Deep response rate

    (% patients with >75% tumor reduction at 6 months ) per RECIST v1.1

    Measured: Up to 2 years

  2. Duration of response (DOR)

    Duration of response (DOR) assessed according to RECIST v1.1

    Measured: Up to 2 years

  3. Disease control rate (DCR)

    Disease control rate (DCR) assessed according to RECIST v1.1

    Measured: Up to 2 years

  4. Progression-free survival (PFS)

    PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to 2 years

  5. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment until death due to any cause.

    Measured: Up to 2 years

  6. Peak Plasma Concentration (Cmax)

    The maximum (or peak) plasma concentration of AK104 in subjects treated with AK104 plus axitinib.

    Measured: Up to 2 years

  7. Area under the plasma concentration versus time curve (AUC)

    AUC = Area under the plasma concentration of AK104-time curve. The area under the plasma concentration time curve (AUC) is a measure of overall exposure to the drug

    Measured: Up to 2 years

  8. Immunogenicity assessment

    Number and percentage of subjects with detectable anti-drug antibodies (ADAs) treated with AK104 plus axitinib

    Measured: Up to 2 years

Timeline

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

  1. First posted25 Feb 2022
  2. Study start6 Jul 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05256472
Sponsor's protocol ID
AK104-213
Status last verified
Jun 2026
First submitted
24 Jan 2022
Last updated
2 Jul 2026
Results posted
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 AK104 and axitinib in people with Renal Cell Carcinoma and First-line Treatment, run by Akeso 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 14 inclusion and 15 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: finished, as of the sponsor's last update on 2 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ORR per RECIST v1.1 as assessed by investigators (time frame: Up to 2 years). 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 NCT05256472.

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 2 Jul 2026.

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