NCT06472895Not yet recruitingPhase 1/2
A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 19 Jun 2024
- Start date
- 20 Jul 2024
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Kidney cancer
- NCT number
- NCT06472895
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 20 Jul 2024 to the primary completion date, 20 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Eligible for surgery.
- 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.
Other illness
- 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.
- History of severe bleeding or coagulation disorders.
- History of abdominal fistula or gastrointestinal perforation related to anti VEGF therapy.
- 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).
Other
- non-clear cell renal cell carcinoma，nccRCC（e.g. chromophobe, papillary)
- Has been pregnant or breastfeeding.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.