Renal Cell CarcinomaPhase 1/2NCT05808608
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
A Phase 1/2 study testing AK104 and Axitinib in people with Renal Cell Carcinoma and First-line Treatment, run by Hao Zeng at 1 site in China.
Trial summary
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). 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, Non Clear Cell Renal Cell Carcinoma
- What is being tested?
- AK104 and Axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2023to Jun 2026
- Phase
- Phase 1/2
- 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
- Patients aged ≥18 years and ≤75 years, with no restriction on gender;
- Diagnosis of RCC with histopathological evidence, with non-clear cell carcinoma confirmed by pathology or genetic testing including pRCC, chRCC, TFE3-rearranged RCC, FH-dRCC, CDC, medullary carcinoma, and unclassified RCC, etc.;
- Patients must be diagnosed with mRCC or unresectable RCC or TNM stage IV (based on the 2017 TNM staging system). Metastasis is evidenced by imaging or pathology, and for patients including in phase II, there must be at least one measurable tumor lesion (based on RECIST v1.1 criteria);
- P atients who had not received any prior systemic therapy, including cytokines, targeted agents, ICIs, or other investigational drugs, or those who had received monotherapy with a targeted agent (limited to first-line targeted agents recommended by NCCN 2022 for renal cell carcinoma) for less than 1 month without disease progression and who had completed the washout period;
- Expected survival of more than 3 months;
- Have signed an informed consent form and be able to comply with the visit and related procedures specified in the protocol;
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- Agree to collect tumor tissue and blood samples required for the study and apply them to related research;
- Important organ and bone marrow function meet the following requirements: Absolute neutrophil count (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (HGB) ≥90g/L; liver function: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5×ULN, serum albumin (ALB) ≥20 g/L; renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CrCI) ≥50mL/min;
- ECOG performance score ≤2.
Who cannot join
- Patients with pathological diagnosis only of clear cell renal cell carcinoma (ccRCC);
- Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways;
- Active brain metastases;
- Patients with a personal history of other malignant tumors different from or histologically different from the primary site of the tumor being evaluated in this study within 3 years, except for patients with papillary thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma, or in situ cervical cancer in a well-controlled state;
- Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to enrollment;
- Patients with diseases requiring systemic glucocorticoid (more than 10mg/day prednisone equivalent dose) or other immunosuppressive drug treatment within 14 days before the first administration of the study drug. Patients without active immune diseases are allowed to receive local, ophthalmic, intra-articular, intranasal, inhaled corticosteroids, and adrenal replacement corticosteroids (more than 10mg/day prednisone dose or equivalent) treatment;
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- Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, colitis, hepatitis, pituitaryitis, vasculitis, nephritis, thyroiditis, etc. Patients with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment, or conditions that are not expected to recur in the absence of external triggering factors are allowed to participate in this study. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Allergic to any component of monoclonal antibodies;
- Patients with other uncontrolled severe diseases, including but not limited to:
- Severe infections in active stage or with poor clinical control;
- HIV-infected (HIV antibody positive);
- Acute or chronic active hepatitis B (HBsAg positive and HBV DNA > 1*103/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA > 15 IU/ml);
- Active pulmonary tuberculosis, etc.;
- III-IV grade congestive heart failure (New York Heart Association classification), persistent symptomatic arrhythmias, uncontrolled atrial fibrillation; multiple echocardiographic assessments of left ventricular ejection fraction (LVEF) below the lower limit of normal values.
- Uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg);
- Any arterial thrombosis, embolism, or ischemia occurred within 6 months before enrollment treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, etc.;
- Diseases requiring warfarin (coumarin) anticoagulation therapy;
- Uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium ion or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy;
- Uncontrolled adrenal insufficiency;
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months.
- Severe, non-healing wounds or ulcers.
- Gastrointestinal diseases affecting gastrointestinal function (such as malabsorption, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).
- Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may lead to the following outcomes: increased risk associated with study participation or administration of study drugs, or interference with the interpretation of study results, and the patient is considered ineligible for the study based on the researcher's judgment;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of First-Line Cadonilimab Plus Axitinib in Patients With Advanced Special Pathological Type Renal Cell Carcinoma: A Prospective, Multi-center, Phase Ib/II Trial
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial.
Primary objective:
Read more
Phase Ib: To evaluate the safety and tolerability of different doses of cadonilimab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types to determine the recommended phase II dose (RP2D).
Phase II: To evaluate the objective response rate (ORR) of cadonilumab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types according to the RECIST 1.1 criteria.
- Conditions
- Renal Cell Carcinoma, First-line Treatment, Non Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma
- Being tested
- 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; Phase 1b: 10mg/kg or 15mg/kg; Phase 2: RP2D intravenously (IV)
AxitinibDrug
An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally
| Study group | Role | What they receive |
|---|---|---|
| Combination treatment group | Experimental | Subjects in this group 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.
Phase Ib Safety Assessment
Incidence and severity of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., dose-limiting toxicity (DLT) during the first treatment cycle, clinically significant abnormal laboratory tests, vital signs, and electrocardiogram (ECG); maximum tolerated dose (MTD), or the maximum administered dose (MAD) when MTD is not reached, as well as the recommended Phase II dose (RP2D).
Measured: 3 years
Phase II Efficacy Assessment: ORR
ORR assessed by the investigator according to RECIST 1.1 criteria. objective response = complete response (CR) + partial response (PR).
Measured: 3 years
Secondary outcomes (5)
Phase Ib Efficacy Assessment
ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) assessed by the investigator according to RECIST 1.1 criteria.
DCR: The proportion of participants achieving CR, PR, or stable disease (SD); DOR: Time from the first occurrence of treatment response (CR or PR) to disease progression or death, whichever occurs first; PFS: Time from the first dose of the treatment drug to disease progression or death due to any cause, whichever occurs first; OS: Time from the first dose of treatment drug to death due to any cause.
Measured: 3 years
Phase II Safety Assessment
Incidence and severity of AEs, clinically significant abnormal laboratory tests, vital signs, and ECG abnormalities.
Measured: 3 years
Phase II Efficacy Assessment
DCR, DOR, PFS, and OS assessed by the investigator according to the RECIST 1.1 criteria.
DCR: The proportion of participants achieving CR, PR, or stable disease (SD); DOR: Time from the first occurrence of treatment response (CR or PR) to disease progression or death, whichever occurs first; PFS: Time from the first dose of the treatment drug to disease progression or death due to any cause, whichever occurs first; OS: Time from the first dose of treatment drug to death due to any cause.
Measured: 3 years
Life quality Questionnaire composite
Evaluate life quality using FKSI-19 and EQ-5D-5L
Measured: 3 years
Pain score
Evaluate pain using visual analogue scale (VAS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start17 Nov 2023
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hao Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hao Zeng, West China Hospital
- Investigators
- Hao Zeng, Professor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808608
- Sponsor's protocol ID
- AK104AXI-ssRCC
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available
Publications
Ljungberg B, Albiges L, Abu-Ghanem Y, Bedke J, Capitanio U, Dabestani S, Fernandez-Pello S, Giles RH, Hofmann F, Hora M, Klatte T, Kuusk T, Lam TB, Marconi L, Powles T, Tahbaz R, Volpe A, Bex A. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2022 Update. Eur Urol. 2022 Oct;82(4):399-410. doi: 10.1016/j.eururo.2022.03.006. Epub 2022 Mar 26.
PubMed 35346519Diaz-Montero CM, Rini BI, Finke JH. The immunology of renal cell carcinoma. Nat Rev Nephrol. 2020 Dec;16(12):721-735. doi: 10.1038/s41581-020-0316-3. Epub 2020 Jul 30.
PubMed 32733094Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.
PubMed 295621452022 ASCO # Oral abstract 106.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of First-Line Cadonilimab Plus Axitinib in Patients With Advanced Special Pathological Type Renal Cell Carcinoma: A Prospective, Multi-center, Phase Ib/II Trial
- ClinicalTrials.gov ID
- NCT05808608
- Acronym / sponsor ID
- AK104AXI-ssRCC
- Conditions
- Renal Cell Carcinoma, First-line Treatment, Non Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hao ZengUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial.
Primary objective:
Phase Ib: To evaluate the safety and tolerability of different doses of cadonilimab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types to determine the recommended phase II dose (RP2D).
Phase II: To evaluate the objective response rate (ORR) of cadonilumab combined with axitinib as first-line therapy in subjects with advanced RCC with special pathological types according to the RECIST 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination treatment group | Experimental | Drug: AK104, Drug: AxitinibSubjects in this group will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥18 years and ≤75 years, with no restriction on gender;
- Diagnosis of RCC with histopathological evidence, with non-clear cell carcinoma confirmed by pathology or genetic testing including pRCC, chRCC, TFE3-rearranged RCC, FH-dRCC, CDC, medullary carcinoma, and unclassified RCC, etc.;
- Patients must be diagnosed with mRCC or unresectable RCC or TNM stage IV (based on the 2017 TNM staging system). Metastasis is evidenced by imaging or pathology, and for patients including in phase II, there must be at least one measurable tumor lesion (based on RECIST v1.1 criteria);
- P atients who had not received any prior systemic therapy, including cytokines, targeted agents, ICIs, or other investigational drugs, or those who had received monotherapy with a targeted agent (limited to first-line targeted agents recommended by NCCN 2022 for renal cell carcinoma) for less than 1 month without disease progression and who had completed the washout period;
- Expected survival of more than 3 months;
Key exclusion criteria (24 listed)
- Patients with pathological diagnosis only of clear cell renal cell carcinoma (ccRCC);
- Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways;
- Active brain metastases;
- Patients with a personal history of other malignant tumors different from or histologically different from the primary site of the tumor being evaluated in this study within 3 years, except for patients with papillary thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma, or in situ cervical cancer in a well-controlled state;
- Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104Anti-PD-1/CTLA-4 bi-specific antibody drug; Phase 1b: 10mg/kg or 15mg/kg; Phase 2: RP2D intravenously (IV) | Drug | Combination treatment group |
| AxitinibAn oral, small molecule, TKI selective for VEGFRs; 5mg bid orally | Drug | Combination treatment group |
Primary outcome
Phase Ib Safety Assessment
Time frame: 3 years
Incidence and severity of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., dose-limiting toxicity (DLT) during the first treatment cycle, clinically significant abnormal laboratory tests, vital signs, and electrocardiogram (ECG); maximum tolerated dose (MTD), or the maximum administered dose (MAD) when MTD is not reached, as well as the recommended Phase II dose (RP2D).
Phase II Efficacy Assessment: ORR
Time frame: 3 years
ORR assessed by the investigator according to RECIST 1.1 criteria. objective response = complete response (CR) + partial response (PR).
5 secondary outcomes
Phase Ib Efficacy Assessment
Time frame: 3 years
Phase II Safety Assessment
Time frame: 3 years
Phase II Efficacy Assessment
Time frame: 3 years
Life quality Questionnaire composite
Time frame: 3 years
Pain score
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 35346519Ljungberg B, Albiges L, Abu-Ghanem Y, Bedke J, Capitanio U, Dabestani S, Fernandez-Pello S, Giles RH, Hofmann F, Hora M, Klatte T, Kuusk T, Lam TB, Marconi L, Powles T, Tahbaz R, Volpe A, Bex A. European Association of Urology Guidelines on Renal Cell Carcinoma: The 2022 Update. Eur Urol. 2022 Oct;82(4):399-410. doi: 10.1016/j.eururo.2022.03.006. Epub 2022 Mar 26.
- Background: PubMed 32733094Diaz-Montero CM, Rini BI, Finke JH. The immunology of renal cell carcinoma. Nat Rev Nephrol. 2020 Dec;16(12):721-735. doi: 10.1038/s41581-020-0316-3. Epub 2020 Jul 30.
- Background: PubMed 29562145Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.
- Background2022 ASCO # Oral abstract 106.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Zeng, Professor principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK104 and Axitinib in people with Renal Cell Carcinoma and First-line Treatment, run by Hao Zeng 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 9 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase Ib Safety Assessment (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT05808608, which also lists 4 linked publications.
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 7 Apr 2026.