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

Hao Zeng

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Sarcomatoid Renal Cell Carcinoma; First-line Treatment; Renal Cell Carcinoma; Non Clear Cell Renal Cell Carcinoma

Treatments: Drug: Axitinib; Drug: AK104

Study type: Interventional

Funder types: Other

Identifiers

NCT05808608

AK104AXI-ssRCC

Details and patient eligibility

About

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

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age≥18, ≤75;
2. histology characteristics accord with special pathological subtypes 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Combination treatment group

Experimental group

Description:

Subjects in this group will receive AK104 (RP2D, administered intravenously) plus Axitinib 5 mg bid, administered orally.

Treatment:

Drug: AK104

Drug: Axitinib