Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

NCT05656144 | Unknown Phase 2

• 1 other identifier: AK104-IIT-006
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 years

Secondary Outcomes (6)

• Disease control rate (DCR)

  up to 2 years

• Duration of response (DoR)

  up to 2 years

• Time to recurrence (TTR)

  up to 2 years

• Progression-free survival (PFS)

  up to 2 years

• Overall survival (OS)

  up to 2 years

Study Arms (1)

Cadonilimab

EXPERIMENTAL

Cadonilimab monotherapy

Device: Cadonilimab

Interventions

Cadonilimab DEVICE

AK104, 6mg/kg, Q2W

Cadonilimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written and signed informed consent.
• \. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent.
• \. 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.
• \. Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma).

You may not qualify if:

• \. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
• \. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
• \. 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).
• \. Active autoimmune diseases;
• \. History of transplantation;
• \. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 19, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 19, 2022

Record last verified: 2022-12