NCT06196775

Brief Summary

To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
9mo left

Started Jan 2024

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress77%
Jan 2024Jan 2027

First Submitted

Initial submission to the registry

December 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 25, 2023

Last Update Submit

December 25, 2023

Conditions

Hepatocellular Carcinoma

Keywords

cadonilimab (anti PD-1/CTLA-4 bispecific antibody)AK112 ( anti VEGF/PD-1 bispecific antibody)

Outcome Measures

Primary Outcomes (1)

  • Progression-Free-Survival

    Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.

    From the first drug administration up to two years

Secondary Outcomes (4)

  • Objective Response Rate

    From the first drug administration up to two years

  • Disease control Rate

    From the first drug administration up to two years

  • Overall survival

    From the first drug administration up to two years

  • Incidence of Adverse Events

    From the first drug administration to within 90 days for the last dose

Study Arms (1)

AK104+AK112

EXPERIMENTAL
Biological: AK104+AK112

Interventions

AK104+AK112BIOLOGICAL

Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.

AK104+AK112

Eligibility Criteria

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

You may qualify if:

  • Histopathologically confirmed HCC
  • Age 18-75 years old
  • ECOG PS 0-1
  • Child Pugh A-B7
  • Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
  • At least one measurable lesion (RECIST 1.1)
  • Enough organ and bone marrow function
  • Expected survival time≥12 weeks
  • Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol

You may not qualify if:

  • Severe complications due to primary liver disease
  • No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
  • Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
  • Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
  • Autoimmune immune disease
  • History of HIV
  • Prognent women
  • The presence of any serious or uncontrolled systemic disease
  • Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University Hospital

Harbin, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Yanqiao Zhang, PhD.

CONTACT

13845120210yanqiaozhang@126.com

Guangyu Wang, PhD.

CONTACT

18249038966guangyuwang@hrbmu.edu.cn

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

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 9, 2024

Study Start

January 31, 2024

Primary Completion

January 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations

CN(1)