Renal Cell CarcinomaPhase 1/2NCT06472895
A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
A Phase 1/2 study testing AK112 monotherapy in people with Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- AK112 monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2024to 20 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- AK112 monotherapy
- Keywords
- RCC，immunotherapy，AK112，first-line treatment
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112 monotherapyDrug
A novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV)，Q3W
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Subjects will receive AK112 (RP2D, administered intravenously，Q3W) Receives: Drug: AK112 monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR per RECIST v1.1 assessed by investigators
ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1
Measured: Up to 2 years
Secondary outcomes (5)
DCR per RECIST v1.1 as assessed by investigators
DCR is the proportion of subjects with complete response(CR), partial response(PR) and stable disease (SD) based on RECIST v1.1
Measured: Up to 2 years
Duration of response (DOR)
Duration of response (DOR) assessed according to RECIST v1.1
Measured: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measured: 3 years
Overall survival (OS)
OS is the time from the first use of a therapeutic drug to death from any cause
Measured: 4 years
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, also types and degree
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start20 Jul 2024 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472895
- Sponsor's protocol ID
- AK112-001-II-RCC
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06472895
- Acronym / sponsor ID
- AK112-001-II-RCC
- Conditions
- Renal Cell Carcinoma
- Keywords
- RCC，immunotherapy，AK112，first-line treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: AK112 monotherapySubjects will receive AK112 (RP2D, administered intravenously，Q3W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK112 monotherapyA novel PD-1/VEGF bispecific antibody; RP2D intravenously (IV)，Q3W | Drug | treatment group |
Primary outcome
ORR per RECIST v1.1 assessed by investigators
Time frame: Up to 2 years
ORR is the proportion of subjects with complete response(CR) and partial response(PR) , based on RECIST v1.1
5 secondary outcomes
DCR per RECIST v1.1 as assessed by investigators
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 4 years
Treatment-related adverse events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK112 monotherapy in people with Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinan Sheng, MD (+86-10-88196348, doctor_sheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR per RECIST v1.1 assessed by investigators (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.