A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma

NCT06367075 | Recruiting Phase 2

• 1 other identifier: AK104-sarcoma-202401
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin.

Conditions

Advanced Soft-tissue Sarcoma

Keywords

Advanced Soft-tissue Sarcoma; cadonilimab; chemotherapy; Anti-PD-1/CTLA4 bispecific antibody

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and iRECIST

  from the first drug administration up to two years

Secondary Outcomes (5)

• Disease control rate (DCR)

  from the first drug administration up to two years

• Duration of response (DOR)

  from the first drug administration up to two years

• Progression-free survival (PFS)

  from the first drug administration up to two years

• Overall survival (OS)

  from the first drug administration up to two years

• Adverse event (AE)

  From the subject signs the ICF to 90 days after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

Study Arms (1)

cadonilimab (AK104) with adriamycin

EXPERIMENTAL

Run-In Period（C1）: cadonilimab10mg/kg, d1 ,q3w; Treatment period（C2\~C7）: adriamycin 25mg/m2, d1-d3，q3w; cadonilimab 10mg/kg, d1, q3w; Maintenance period（C8\~）: cadonilimab 10mg/kg, d1, q3w

Drug: Cadonilimab; Drug: Adriamycin

Interventions

Cadonilimab DRUG

injectable solution

Also known as: AK104

cadonilimab (AK104) with adriamycin

Adriamycin DRUG

injectable solution

Also known as: Doxorubicin

cadonilimab (AK104) with adriamycin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were pathologically confirmed soft tissue sarcoma (soft tissue sarcomas other than alveolar/embryonal rhabdomyosarcoma, clear cell sarcoma, extraosseous Ewing sarcoma, alveolar soft tissue sarcoma, well differentiated liposarcoma, extraosseous myxoid chondrosarcoma, etc.)
• The patient was diagnosed as progressive and the investigators determined that the lesion was not suitable for surgical treatment
• The patients had not received systemic therapy (including chemotherapy, targeted therapy and bioimmunotherapy) for advanced soft tissue sarcoma. More than 6 months have passed since the end of neoadjuvant/adjuvant therapy (including chemotherapy, targeted therapy, bioimmunotherapy, etc.), and the cumulative dose of adriamycin used in the past was ≤100 mg/m2
• In patients with measurable disease, lesions are defined and monitored by RECIST v1.1
• Aged ≥ 18 years old, \< 60 years old
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, amputees can be 0-2
• Expected survival \> 3 months
• Adequate organ and bone marrow function, defined as follows: ① Blood routine (14 days before screening without blood transfusion, without G-CSF, without drug correction): neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 100 × 10\^9/L; hemoglobin (Hb) ≥ 100 g/L; ② Blood biochemistry: serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60ml/min; total bilirubin (TBIL) ≤ 1.5 × ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 × ULN, The subjects with liver metastasis should be ≤ 5 × ULN; ③ Coagulation function: international normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; ④ Urinalysis: urine protein \< 2 +; if urine protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g; ⑤ thyroid stimulating hormone (TSH) ≤ ULN and ≥ LLN; if abnormal, T3 and T4 levels should be investigated, normal T3 and T4 levels can be included
• Cardiac function:1) 12-lead electrocardiogram showed no severe arrhythmias, QTcF ≤ 480 ms; 2) No signs of myocardial ischemia; 3) LVEF ≥55% by cardiac ultrasound (measured by the biplane Simpson method); 4) NT-proBNP \< age cutoff value; 5) Troponin within normal values.
• Agree and have signed informed consent, willing and able to comply with scheduled visits, study treatment, laboratory tests and other test procedures
• Women of childbearing potential should have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices \[IUDs\]) throughout the period of taking study treatment and for at least 3 months after the last dose of study drug(s). For men, surgical sterilization or consent to appropriate contraception during observation and up to 90 days after the last treatment should be used

You may not qualify if:

• known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components
• Known allergy to recombinant humanized anti-CTLA-4 monoclonal antibody drug and its components
• known allergy to any component of the cadonilimab formulation
• Patients with cardiac disease class II or higher as determined by the New York Heart Association (NYHA) score
• Palliative radiotherapy within 2 weeks prior to the first dose
• Other active malignancy within 5 years prior to enrollment. Except for locally curable malignancies (manifested as cured) such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, endometrial carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study
• Active autoimmune disease requiring systemic therapy within 2 years prior to the start of study treatment, or autoimmune disease that, in the judgment of the Investigator, is likely to recur or for which treatment is planned; except for the following: skin diseases not requiring systemic therapy (e.g., vitiligo, alopecia areata, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only a stable dose of hormone replacement therapy; well-controlled type I diabetes mellitus; childhood well-controlled type I diabetes mellitus; subjects whose childhood asthma has completely resolved and does not require any intervention in adulthood; and subjects who, in the judgment of the investigator, have a disease that will not recur in the absence of external triggers
• Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) that is active or requires clinical management
• Subjects will require systemic therapy with corticosteroids (\>10 mg/day of prednisone equivalents) or other immunosuppressive medications within 14 days of administration of study drug. Inhaled or topical topical steroids and adrenal replacement doses \>10 mg/day of prednisone equivalent are allowed in the absence of active autoimmune disease. Topical, ocular, intra-articular, intranasal and inhaled corticosteroids (with minimal systemic absorption) are permitted in subjects. Physiologic replacement doses of systemic corticosteroids are permitted, even if \>10 mg/day of prednisone equivalent. Short-term use of corticosteroids is permitted for prophylaxis (e.g., contrast allergy) or for treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reactions due to contact allergens)
• Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome
• History of known allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• Known presence or history of interstitial lung disease
• Received a live vaccine within 30 days prior to the first dose of cadonilimab or plan to receive a live vaccine during the study period
• Subjects with necrotic lesions detected on examination within 4 weeks prior to enrollment that, in the judgment of the investigator, pose a risk of major bleeding

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Sun Yat-sen University: collaborator
• Yunnan Cancer Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Interventions

Doxorubicin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• jing chen, doctor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

li fan, doctor

CONTACT

+86-027-85873501; medbifish@hust.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: SPONSOR

Model Details: cadonilimab (AK104) with adriamycin

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)