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Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05656144
Collaborator
(none)
49
Enrollment
1
Arm
28
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Cadonilimab
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Single-center, Open-label, Phase II Study Assessing Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cadonilimab

Cadonilimab monotherapy

Device: Cadonilimab
AK104, 6mg/kg, Q2W

Outcome Measures

Primary Outcome Measures

  1. Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator [up to 2 years]

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

Secondary Outcome Measures

  1. Disease control rate (DCR) [up to 2 years]

    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.

  2. Duration of response (DoR) [up to 2 years]

    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.

  3. Time to recurrence (TTR) [up to 2 years]

    TTR is defined as the time to response base on RECIST v1.1

  4. Progression-free survival (PFS) [up to 2 years]

    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)

  5. Overall survival (OS) [up to 2 years]

    Overall survival is defined as the time from the start of treatment with Cadonilimab until death due to any cause.

  6. AE [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]

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Written and signed informed consent.
    1. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent.
    1. 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.
    1. 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.
    1. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
    1. 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).
    1. Active autoimmune diseases;
    1. History of transplantation;
    1. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Cancer Hospital & Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier:
NCT05656144
Other Study ID Numbers:
  • AK104-IIT-006
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sarcoma

Study Results

No Results Posted as of Dec 19, 2022