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Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

Primary Purpose

Soft Tissue Sarcoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cadonilimab
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Written and signed informed consent. 2. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent. 3. Pathologically confirmed unresectable or metastatic soft tissue sarcoma, mainly including Undifferentiated pleomorphic sarcoma/malignant fiber histiocytoma, Alveolar soft part sarcoma, dedifferentiated liposarcoma, fibrosarcoma, Leiomyosarcoma, Anigosarcoma, Synovial sarcoma. 4. Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma). Exclusion Criteria: 1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. 3. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc). 4. Active autoimmune diseases; 5. History of transplantation; 6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cadonilimab

    Arm Description

    Cadonilimab monotherapy

    Outcomes

    Primary Outcome Measures

    Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Secondary Outcome Measures

    Disease control rate (DCR)
    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
    Duration of response (DoR)
    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
    Time to recurrence (TTR)
    TTR is defined as the time to response base on RECIST v1.1
    Progression-free survival (PFS)
    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first)
    Overall survival (OS)
    Overall survival is defined as the time from the start of treatment with Cadonilimab until death due to any cause.
    AE
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

    Full Information

    First Posted
    December 9, 2022
    Last Updated
    December 9, 2022
    Sponsor
    Peking University Cancer Hospital & Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05656144
    Brief Title
    Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma
    Official Title
    A Single-arm, Single-center, Open-label, Phase II Study Assessing Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Cancer Hospital & Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the efficacy and safety of Cadonilimab monotherapy in the treatment of patients with advanced soft tissue sarcoma who have received at least one chemotherapy (including anthracyclines) for advanced diseases (excluding alveolar soft part sarcoma).
    Detailed Description
    After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period (≤28 days) to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be treated with Cadonilimab monotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Sarcoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    49 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cadonilimab
    Arm Type
    Experimental
    Arm Description
    Cadonilimab monotherapy
    Intervention Type
    Device
    Intervention Name(s)
    Cadonilimab
    Intervention Description
    AK104, 6mg/kg, Q2W
    Primary Outcome Measure Information:
    Title
    Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
    Description
    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
    Time Frame
    up to 2 years
    Secondary Outcome Measure Information:
    Title
    Disease control rate (DCR)
    Description
    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
    Time Frame
    up to 2 years
    Title
    Duration of response (DoR)
    Description
    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
    Time Frame
    up to 2 years
    Title
    Time to recurrence (TTR)
    Description
    TTR is defined as the time to response base on RECIST v1.1
    Time Frame
    up to 2 years
    Title
    Progression-free survival (PFS)
    Description
    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first)
    Time Frame
    up to 2 years
    Title
    Overall survival (OS)
    Description
    Overall survival is defined as the time from the start of treatment with Cadonilimab until death due to any cause.
    Time Frame
    up to 2 years
    Title
    AE
    Description
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
    Time Frame
    From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Written and signed informed consent. 2. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent. 3. Pathologically confirmed unresectable or metastatic soft tissue sarcoma, mainly including Undifferentiated pleomorphic sarcoma/malignant fiber histiocytoma, Alveolar soft part sarcoma, dedifferentiated liposarcoma, fibrosarcoma, Leiomyosarcoma, Anigosarcoma, Synovial sarcoma. 4. Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma). Exclusion Criteria: 1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. 3. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc). 4. Active autoimmune diseases; 5. History of transplantation; 6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

    12. IPD Sharing Statement

    Learn more about this trial

    Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

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