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Advanced Soft-tissue SarcomaPhase 2NCT06367075

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

A Phase 2 study testing Cadonilimab and Adriamycin in people with Advanced Soft-tissue Sarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Soft-tissue Sarcoma
What is being tested?
Cadonilimab and Adriamycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
9 Oct 2024to 31 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Serious infection, including but not limited to concomitant complications requiring hospitalization, sepsis, or severe pneumonia, within 4 weeks prior to first dose
  • Known active tuberculosis (TB). Subjects suspected of having active TB will be examined by chest X-ray, sputum, and exclusion by clinical signs and symptoms
  • Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA >1000 IU/mL, and patients with active hepatitis C should be excluded. Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stabilized hepatitis B patients (HBV DNA <1000 IU/mL), and cured hepatitis C patients may be enrolled. For HCV Ab-positive subjects, participation in the study is eligible only if the HCV RNA test result is negative
  • Major surgical procedure within 30 days prior to the first dose of cadonilimab or have not fully recovered from a prior procedure. Localized surgical procedures (e.g., systemic port placement, core needle biopsy, and prostate biopsy) are permitted provided that the procedure is completed at least 24 hours prior to the time of the first dose of study treatment medication
  • Presence of known meningeal metastases, spinal cord compression, molluscum contagiosum disease, or active brain metastases. However, enrollment is allowed for subjects who meet the following requirements and have a measurable lesion outside the CNS: 1) previously untreated and currently asymptomatic (e.g., no neurologic deficits, seizures, or other signs and symptoms typical of CNS metastases; glucocorticoid therapy is not required); 2) asymptomatic after treatment has been imaging stable for at least 4 weeks prior to the initiation of study treatment (e.g., no new or enlarging brain metastatic lesion ) and have discontinued systemic glucocorticoid and anticonvulsant medication for at least 2 weeks
  • Subjects with pleural effusions, pericardial effusions, or ascites that, in the judgment of the Investigator, remain unstably controlled using repeated drainage or other methods
  • Uncontrolled co-morbidities, including symptomatic congestive heart failure (grade 3 or 4 as determined by the New York Heart Association functional classification), uncontrolled hypertension, unstable angina, poorly controlled cardiac arrhythmias, acute or evidence of ongoing myocardial ischemia, severe active peptic ulcer disease or gastritis, or mental illness/social disease that would limit the subject's ability to comply with the study requirements or interfere with the subject's ability to provide written mental illness/social condition that would limit the subject's ability to provide informed consent. Any arterial thromboembolic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, history of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 6 months prior to enrollment
  • Unreversed toxicity from prior antineoplastic therapy, defined as toxicity that has not returned to NCI CTCAE version 5.0 grade 0 or 1, or to a level specified in the inclusion/exclusion criteria (except alopecia areata). Subjects who experience irreversible toxicity that is not expected to worsen with administration of study drug (e.g., hearing loss) may be included in the study after consultation with the Medical Ombudsman. Subjects with radiotherapy-induced long-term toxicity that, in the judgment of the Investigator, is not reversible may be included in the study after consultation with the Medical Ombudsman
  • Females who are pregnant or breastfeeding
  • Any condition that, in the opinion of the Investigator, may render treatment with the study drug risky or will interfere with the evaluation of the study drug or the safety of the subject or the resolution of the study results

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

li fan, doctor contact

+86-027-85873501

medbifish@hust.edu.cn

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430000

    jing chen, doctor, +86-027-85873501, chenjingunion@163.com

    li fan

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Cadonilimab(AK104) With Adriamycin for First-line Treatment of Advanced Soft Tissue Sarcoma: a Multicenter, Single-arm, Phase II Clinical Trial

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.

Read the detailed description

In this study, the screening period does not exceed 28 days, and subjects who are qualified after completion of the screening examination and evaluation entered the treatment period and undergo study treatment and visits as specified in the protocol. In particular, tumor imaging assessments are performed every 2 cycles during the first 16 cycles; thereafter, tumor imaging assessments are performed every 4 cycles.

Being tested
Cadonilimab, Adriamycin
Keywords
Advanced Soft-tissue Sarcoma, cadonilimab, chemotherapy, Anti-PD-1/CTLA4 bispecific antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CadonilimabDrug

    Also called AK104

    injectable solution

  • AdriamycinDrug

    Also called Doxorubicin

    injectable solution

Study groups in NCT06367075
Study groupRoleWhat they receive
cadonilimab (AK104) with adriamycinExperimentalRun-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
Receives: Drug: Cadonilimab; Drug: Adriamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from the first drug administration up to two years

Secondary outcomes (5)

  1. Disease control rate (DCR)

    Proportion of patients whose best overall response is either CR, PR, or SD

    Measured: from the first drug administration up to two years

  2. Duration of response (DOR)

    Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first

    Measured: from the first drug administration up to two years

  3. Progression-free survival (PFS)

    Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first

    Measured: from the first drug administration up to two years

  4. Overall survival (OS)

    Time from the date of first study treatment administration to the date of death due to any cause

    Measured: from the first drug administration up to two years

  5. Adverse event (AE)

    To assess the safety and tolerability of cadonilimab plus adriamycin in participants with advanced soft tissue sarcoma

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start9 Oct 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
cadonilimab (AK104) with adriamycin
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06367075
Sponsor's protocol ID
AK104-sarcoma-202401
Status last verified
Jul 2025
First submitted
10 Apr 2024
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab and Adriamycin in people with Advanced Soft-tissue Sarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact li fan, doctor (+86-027-85873501, medbifish@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: from the first drug administration up to two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06367075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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