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

Sponsor
Hao Zeng (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05808608
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
30
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of AK104 Plus Axitinib in Advanced/Metastatic Specific Subtypes of Renal Cell Carcinoma
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combination treatment group

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

Drug: AK104
Anti-PD-1/CTLA-4 bi-specific antibody drug; RP2D intravenously (IV)

Drug: Axitinib
An oral, small molecule, TKI selective for VEGFRs; 5mg bid orally

Outcome Measures

Primary Outcome Measures

  1. ORR per RECIST v1.1 and imRECIST as assessed by investigators [3 years]

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

  2. 12-month PFS rate per RECIST v1.1 and imRECIST as assessed by investigators [12 months]

    Progression is assessed by investigators based on RECIST v1.1 and imRECIST, including disease progression or death from any cause.

Secondary Outcome Measures

  1. DCR per RECIST v1.1 and imRECIST as assessed by investigators [3 years]

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

  2. OS [3 years]

    OS is the time from the first use of a therapeutic drug to death from any cause

  3. PFS per RECIST v1.1 and imRECIST as assessed by investigators [3 years]

    PFS is the time from the first use of a therapeutic drug to disease progression or death from any cause, progression is assessed by investigators based on RECIST v1.1 and imRECIST

  4. Life quality Questionnaire composite [3 years]

    Evaluate life quality using EuroQol Five Dimensions Questionnaire (EQ-5D). EQ-5D included two aspects: EQ-5D Descriptive System and the EQ-5D visual analogue scale (EQ-VAS). In the description system, health status will be evaluated in 5 aspects: Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression. EQ-VAS ranges from 0 to 100, higher scores indicate better health.

  5. Pain score [3 years]

    Evaluate pain using visual analogue scale (VAS), range from 0 to 10, higher scores predict a poor prognosis.

Other Outcome Measures

  1. Treatment-related adverse events [3 years]

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ≥1.5109, platelets ≥100109, 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital Chengdu Sichuan China 610041

Sponsors and Collaborators

  • Hao Zeng

Investigators

  • Principal Investigator: Hao Zeng, Professor, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hao Zeng, professor, West China Hospital
ClinicalTrials.gov Identifier:
NCT05808608
Other Study ID Numbers:
  • AK104AXI-ssRCC
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Axitinib

Study Results

No Results Posted as of Apr 11, 2023