A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma
Hao Zeng
33 participants
Nov 17, 2023
INTERVENTIONAL
Conditions
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). 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.
Eligibility
Inclusion Criteria9
- age≥18, ≤75;
- 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 ;
- metastatic renal cell carcinoma (TNM IV stage according to the 2009 TNM Staging system).
- Patients who have not previously received systemic therapy, ECOG (Eastern Cooperative Oncology Group)≤2;
- expected survival \>3 months;
- all patients signed informed consent.
- blood routine indexes: neutrophils ≥1.5\*109, platelets ≥100\*109, hemoglobin ≥90g/L;
- 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
- 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 Criteria10
- 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;
- renal decompensation requires hemodialysis or peritoneal dialysis;
- 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;
- severe active clinical infection;
- patients with coagulation disorder or bleeding constitution;
- major surgery or severe trauma was performed within 4 weeks before enrollment;
- a history of allogeneic organ transplantation or bone marrow transplantation;
- drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
- known or suspected allergy to the study drug;
- those who received treatment other than this study within 4 weeks prior to and during the study period.
Interventions
Anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)
An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05808608