A Study of AK104 Plus Axitinib in Advanced/Metastatic Specific Subtypes of Renal Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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 specific 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. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hao Zeng
• Treatments: Axitinib

Criteria

Inclusion Criteria:

1. age≥18, ≤75;

2. histology characteristics accord with specific types of RCC, papillary renal cell carcinoma, chromophobic cell carcinoma, TFE3 rearrangement renal cell carcinoma, FH-deficient renal cell carcinoma, collecting duct carcinoma, medullary carcinoma, sarcomatoid carcinoma (>10%), unclassified renal cell carcinoma ;

3. metastatic renal cell carcinoma (TNM IV stage according to the 2009 TNM Staging system).

4. Patients who have not previously received systemic therapy, ECOG (Eastern Cooperative Oncology Group)≤2;

5. expected survival >3 months;

6. all patients signed informed consent.

7. blood routine indexes: neutrophils ≥1.5*109, platelets ≥100*109, hemoglobin ≥90g/L;

8. liver function: bilirubin ≤ normal upper limit 1.5 times, ALT/AST≤ normal upper limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit

9. the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.

Exclusion Criteria:

1. other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years;

2. renal decompensation requires hemodialysis or peritoneal dialysis;

3. arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than NYHA Ⅱ level; Hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled;

4. severe active clinical infection;

5. patients with coagulation disorder or bleeding constitution;

6. major surgery or severe trauma was performed within 4 weeks before enrollment;

7. a history of allogeneic organ transplantation or bone marrow transplantation;

8. drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;

9. known or suspected allergy to the study drug;

10. those who received treatment other than this study within 4 weeks prior to and during the study period.