NCT04542837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2020

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

September 2, 2020

Last Update Submit

September 11, 2024

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

  • ORR

    objective response rate (ORR) based on the RECIST 1.1 by investigator

    1 year after the last patient's enrollment

Secondary Outcomes (7)

  • ORR

    1 year after the last patient's enrollment

  • DCR

    1 year after the last patient's enrollment

  • DOR

    1 year after the last patient's enrollment

  • TTR

    1 year after the last patient's enrollment

  • PFS

    1 year after the last patient's enrollment

  • +2 more secondary outcomes

Study Arms (1)

KN046 plus Lenvatinib

EXPERIMENTAL
Biological: KN046Drug: Lenvatinib

Interventions

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.

KN046 plus Lenvatinib
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.

KN046 plus Lenvatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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；
  • 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；

You may not qualify if:

  • 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;
  • 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);
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Interventions

lenvatinib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Surgery

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 9, 2020

Study Start

September 11, 2020

Primary Completion

February 23, 2022

Study Completion

March 15, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(2)