HCCPhase 2NCT04542837
The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
A Phase 2 study testing KN046 and Lenvatinib in people with HCC, run by Peking University Cancer Hospital & Institute at 2 sites in China.
Trial summary
This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- KN046 and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesChina
- Study dates
- 11 Sep 2020to 15 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
- Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
- Age ≥18 years or ≤75 years for both genders；
- ECOG performance status: 0-1；
- Child Pugh score≤7；
- LVEF≥50% or above LLN of the research institution；
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- Enough organ function；
- Has at least one measurable lesion based on RECIST 1.1；
- Life expectancy ≥3 months；
- Patients must be able to understand and willing to sign a written informed consent document；
Who cannot join
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
- Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
- Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
- Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
- Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
- Any previous or current active autoimmune disease or history of autoimmune disease;
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- History of hepatic encephalopathy or liver transplantation;
- History of interstitial lung disease or non-infectious pneumonia;
- History of allergic reactions to related drugs;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;
- With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable;
- Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months;
- Untreated hepatitis infection: HBV DNA>2000IU/ml or10000 copies/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive;
- Evidence of active pulmonary tuberculosis (TB);
- Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
About this study
Official title: A Phase II Study Evaluating the Safety and Efficacy of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.
- Conditions
- HCC
- Being tested
- KN046, Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046Biological
Subjects enrolled in the study will be intravenously administered KN046 5mg/kg every 3 weeks (Q3W), until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.
LenvatinibDrug
Subjects enrolled in the study will receive lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW<60 kg) orally once a day (QD) ,until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.
| Study group | Role | What they receive |
|---|---|---|
| KN046 plus Lenvatinib | Experimental | Not described Receives: Biological: KN046; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate (ORR) based on the RECIST 1.1 by investigator
Measured: 1 year after the last patient's enrollment
Secondary outcomes (7)
ORR
objective response rate (ORR) based on the mRECIST 1.1 and imRECIST respectively by investigator
Measured: 1 year after the last patient's enrollment
DCR
disease control rate (DCR) based on the RECIST 1.1，mRECIST 1.1 and imRECIST respectively by investigator
Measured: 1 year after the last patient's enrollment
DOR
duration of response (DOR) based on the RECIST 1.1，mRECIST 1.1 and imRECIST respectively by investigator
Measured: 1 year after the last patient's enrollment
TTR
time to response (TTR) based on the RECIST 1.1，mRECIST 1.1 and imRECIST respectively by investigator
Measured: 1 year after the last patient's enrollment
PFS
Measured: 1 year after the last patient's enrollment
OS-12m rate
12-month overall survival rate
Measured: 1 year after the last patient's enrollment
OS
overall survival
Measured: 2 year after the last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start11 Sep 2020
- Primary completion23 Feb 2022
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baocai Xing, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542837
- Sponsor's protocol ID
- 20200825
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Safety and Efficacy of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04542837
- Acronym / sponsor ID
- 20200825
- Conditions
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 9 Sep 2020 (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 ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN046 plus Lenvatinib | Experimental | Biological: KN046, Drug: Lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology；
- Barcelona Clinic Liver Cancer (BCLC) Stage B or C；
- Age ≥18 years or ≤75 years for both genders；
- ECOG performance status: 0-1；
- Child Pugh score≤7；
Key exclusion criteria (16 listed)
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc;
- Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement;
- Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);
- Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration;
- Subjects who need corticosteroids or immunosuppressive agents for systemic therapy;
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 |
|---|---|---|
| KN046Subjects enrolled in the study will be intravenously administered KN046 5mg/kg every 3 weeks (Q3W), until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate. | Biological | KN046 plus Lenvatinib |
| LenvatinibSubjects enrolled in the study will receive lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW<60 kg) orally once a day (QD) ,until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate. | Drug | KN046 plus Lenvatinib |
Primary outcome
ORR
Time frame: 1 year after the last patient's enrollment
objective response rate (ORR) based on the RECIST 1.1 by investigator
7 secondary outcomes
ORR
Time frame: 1 year after the last patient's enrollment
DCR
Time frame: 1 year after the last patient's enrollment
DOR
Time frame: 1 year after the last patient's enrollment
TTR
Time frame: 1 year after the last patient's enrollment
PFS
Time frame: 1 year after the last patient's enrollment
OS-12m rate
Time frame: 1 year after the last patient's enrollment
OS
Time frame: 2 year after the last patient's enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KN046 and Lenvatinib in people with HCC, run by Peking University Cancer Hospital & Institute at 2 sites in China.
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 10 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year after the last patient's enrollment). 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 19 Sep 2024.