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Trial Title:
A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
NCT ID:
NCT06472895
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Conditions: Keywords:
RCC，immunotherapy，AK112，first-line treatment
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK112 monotherapy
Description:
A novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV)，Q3W
Arm group label:
treatment group
Summary:
This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety
of AK112（ivonescimab）monotherapy as first-line treatment for favourable risk
advanced/metastatic renal cell carcinoma (a/m RCC).
Subjects will receive AK112 until disease progression, unacceptable toxic effects,
death，a decision by the physician or patient to withdraw from the trial，or AK112 exposure
over 2 years.
The study set dose exploration stage and dose expansion stage respectively. Firstly,
include a few subjects for observation in dose exploration stage, and select appropriate
dose to enter expansion, then continue to include more subjects to further assessment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Provide written informed consent/assent for the trial.
- Be ≥18 and ≤ 75 years of age on day of signing informed consent, no matter male or
female.
- IMDC favourable risk（IMDC score 0）.
- ECOG PS 0-1.
- Have estimated life expectancy of at least 3 months.
- Have histologically or cytologically confirmed diagnosis of RCC with mainly clear
cell carcinoma component.
- Have received no prior systemic therapy for advanced RCC，Including but not limited
to Immunotherapy, target therapy, chemotherapy, biological therapy, etc.
Note: Prior neoadjuvant/adjuvant therapies are acceptable if disease progression occurred
> 6 months after last dosage of neoadjuvant/adjuvant treatment.
- Have measurable disease per RECIST v1.1 .
- Adequate organ function.
- Contraception from entering the trial，until 120 days after the last administration
of the investigational drug.
- Willing to comply with the scheduled visits, treatment plans, and other requirements
of the trial.
Exclusion Criteria:
- non-clear cell renal cell carcinoma，nccRCC（e.g. chromophobe, papillary)
- Has active autoimmune disease that might deteriorate when receiving an
immunostimulatory agents. Subjects with diabetes type I, vitiligo, psoriasis,
hypo-or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- Has a known additional malignancy that has progressed or has required active
treatment in the last 5 years.
Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin
that has undergone potentially curative therapy or carcinoma in situ are not excluded.
- Eligible for surgery.
- History of severe bleeding or coagulation disorders.
- History of abdominal fistula or gastrointestinal perforation related to anti VEGF
therapy.
- Has previously received systemic therapy.
- Has newly diagnosed brain metastases or known symptomatic brain metastases requiring
steroids.
- Had major surgery 4 weeks prior to receiving first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 14 days prior to receiving first dose
of trial treatment.
- Has an active tuberculosis and syphilitic infection.
- Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV
antibodies).
- Has known active Hepatitis B (e.g., Hepatitis B surface antigen [HBsAg] reactive and
HBV-DNA>2000 IU/ml) or Hepatitis C virus (e.g., HCV RNA [qualitative] is detected).
- Has been pregnant or breastfeeding.
- Assessed by the investigator to be unable or unwilling to comply with the
requirements of the protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 20, 2024
Completion date:
December 20, 2027
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06472895
