Clinical trial · Interventional
Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma
A Single-arm, Single-center, Open-label, Phase II Study Assessing Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma
NCT05656144CI-TRIAL-00062757unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cadonilimab
- description
- Cadonilimab monotherapy
- interventionNames
- Device: Cadonilimab
Primary outcomes (1)
- measure
- Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator
- timeFrame
- up to 2 years
- description
- The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Secondary outcomes (6)
- measure
- Disease control rate (DCR)
- timeFrame
- up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.