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Sarcoma, Soft TissueEarly Phase 1NCT06114173

Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma

A Early Phase 1 study testing Cardunilizumab in people with Sarcoma, Soft Tissue, run by Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this type of study: clinical trial is to observe the efficacy and safety of cardunilizumab in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS), smooth muscle sarcoma, mucinous fibrosarcoma, and poorly… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
Cardunilizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
1 Nov 2022to 30 Nov 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • agree to sign the informed consent form.
  • 18 years ≤ age < 75 years.
  • Pathologic subtypes include undifferentiated sarcoma (UPS), smooth muscle sarcoma, mucinous fibrosarcoma, poorly differentiated/ dedifferentiated/ pleomorphic Liposarcoma; diagnosis confirmed by pathology at a tertiary care hospital.
  • soft tissue sarcoma evaluated as metastatic or inoperable.
  • previous systemic therapy including at least anthracycline-based chemotherapeutic agents.
  • at least one measurable lesion (CT or MRI); Tissue specimen which can be safely obtained by vacutainer before and during treatment.
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  • ECOG physical status score of 0-1.
  • an expected survival time of >12 weeks.
  • Normal major organ function, i.e., the following criteria are met:
  • Hematology: i. Absolute neutrophil count ANC ≥ 1.5 × 109/L (1,500/mm3). ii. Platelet count ≥ 80 × 109/L (80,000/mm3 ). iii.Hemoglobin ≥ 90 g/L. b) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN. ii. AST and ALT ≤ 2.5 × ULN. iii. serum albumin (ALB) ≥ 28 g/L. iv. serum bilirubin (ALB) ≤ 1.5 × ULN. c) Coagulation function: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
  • Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.
  • Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test is not confirmed).
  • The subject is willing and able to comply with the schedule of visits, treatment regimens, laboratory tests, and other requirements of the study.

Who cannot join

  • patients with active (symptomatic) brain metastases; or uncontrolled medical conditions with severe insufficiency of vital organ function including liver, kidney, heart, lung or bone marrow.
  • subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers with HBV DNA greater than 1000 IU/mL; and subjects with active viral hepatitis C.
  • a history of known positive tests for human immunodeficiency virus or known acquired immunodeficiency syndrome.
  • active or potentially relapsing autoimmune disease;
  • history of severe allergic reaction to any monoclonal antibody and/or components of the study drug.
  • known active tuberculosis TB and subjects suspected of having active TB will be required to undergo a clinical examination to exclude known active syphilis infection.
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  • history of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy or current non-infectious pneumonia.
  • a serious infection occurring within 4 weeks prior to the first dose, including, but not limited to, an active infection with comorbidities requiring hospitalization, sepsis, or severe pneumonia treated with systemic anti-infective therapy within 2 weeks prior to the first dose.
  • serious illness or concomitant non-neoplastic conditions such as neurological disorders, psychiatric disorders, infectious diseases, or laboratory abnormalities.
  • major surgical procedure or serious traumatic injury within 30 days prior to the first dose of the drug, or major surgical procedure planned within 30 days of the first dose of the drug; minor localized surgical procedures within 3 days prior to the first dose of the drug
  • known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • subjects requiring systemic therapy with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration of study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted. Topical, ocular, intra-articular, intranasal and inhaled corticosteroids are permitted in subjects. Physiologic replacement doses of systemic corticosteroids are allowed, even if >10 mg/day of prednisone equivalent. Short-term use of corticosteroids for prevention or treatment of non-autoimmune diseases is permitted.
  • Patients with clinically significant cardiovascular disease; 1) Myocardial infarction, unstable angina, pulmonary embolism, aortic coarctation, deep vein thrombosis, and any arterial thromboembolic event within 6 months prior to dosing; 2) New York Heart Association (NYHA) heart failure ≥ Class II; 3) Severe arrhythmias requiring long-term pharmacologic intervention; asymptomatic atrial fibrillation with stable ventricular rate is permitted. patients; 4) Cerebrovascular event (CVA) within 6 months prior to randomization; 5) Left ventricular ejection fraction (LVEF) < 50%; 6) previous history of myocarditis or cardiomyopathy. 14.
  • concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or an interventional study.
  • currently undergoing treatment for cancer (chemotherapy, radiotherapy, immunotherapy, or biologic therapy).
  • prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody.
  • have received a live vaccine within 30 days prior to the first dose or plan to receive a live vaccine during the study period.
  • known history of mental illness, substance abuse, alcoholism, or drug addiction.
  • pregnant or breastfeeding female.
  • any pre-existing or current medical condition, treatment, or laboratory test abnormality that could confound the results of the study, interfere with the subject's ability to participate in the study throughout the study, or participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

Other trials in China

About this study

Official title: Efficacy and Safety Study of Cardunolizumab in Soft Tissue Sarcoma After Failure of at Least Anthracycline-based Chemotherapy: a Single-arm Clinical Trial

The goal of this type of study: clinical trial is to observe the efficacy and safety of cardunilizumab in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS), smooth muscle sarcoma, mucinous fibrosarcoma, and poorly differentiated/undifferentiated/polymorphic liposarcoma, etc.) . The main question[s] it aims to answer are:

  • Cardunilizumab is effective in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS),smooth muscle sarcoma, mucinous fibrosarcoma, and poorly differentiated/undifferentiated/polymorphic liposarcoma) is effective .
  • Cardunilizumab has manageable adverse effects. Participants will be given Cardunolizumab 6mg/kg once every 2 weeks free
Read the detailed description

Some important factors for applying for this clinical trial:

  1. sarcomas are dangerous, subtypically complex, and lack effective treatment. Soft Tissue Sarcoma treatment is looking for new drugs to improve patient prognosis.
  2. PD-1 inhibitor monotherapy has shown initial efficacy in some soft tissue sarcoma subtypes.
  3. Dual immunotherapy targeting PD-1 and CTLA-4 is more effective in the treatment of malignant tumors.
  4. The "two-in-one" dual-antibody cardunculizumab, which is more potent and less toxic, has been approved for marketing by the Fast Track Review.
  5. We hypothesize that the treatment of soft tissue sarcoma with cadunilizumab is safer and more effective than currently available immunotherapy options; however, this has not yet been reported.
Being tested
Cardunilizumab
Medical subject headings
Sarcoma

What participants receive

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

  • CardunilizumabDrug

    Also called PD-1/CTLA-4 Bispecific Antibody

    Cardunolizumab 6mg/kg was administered every 2 weeks, with the first evaluation at 8 weeks of treatment and subsequent evaluations every 12 weeks.

Study groups in NCT06114173
Study groupRoleWhat they receive
drug-dosing groupExperimentalCardunolizumab 6mg/kg was administered every 2 weeks, with the first evaluation at 8 weeks of treatment and subsequent evaluations every 12 weeks.
Receives: Drug: Cardunilizumab

What is being measured

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

  1. Objective response rate，ORR

    Tumor volume reduction of up to 30%（According to RECIST 1.1 efficacy evaluation criteria）

    Measured: 24 months

Secondary outcomes (4)

  1. Incidence of adverse events

    according to criteria CTCAE 5.0,the ratio of AE and SAE which were defined by the common terminology criteria for adverse events,CTCAE.

    Measured: 24 months

  2. Incidence of immune-related adverse events

    Adverse effects due to the use of immunotherapy

    Measured: 24 months

  3. overall survival,OS

    Time from initiation of immunotherapy to death or time lost to visit.

    Measured: 24 months

  4. progression-free survival,PFS

    Time from initiation of immunotherapy to disease progression or death from other causes.

    Measured: 24 months

Timeline

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

  1. First posted2 Nov 2023
  2. Study start1 Nov 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Nov 2024 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06114173
Sponsor's protocol ID
202303215
Status last verified
Sep 2023
First submitted
6 Oct 2023
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: we will share the some dates to the website:http://www.medresman.org.cn/login.aspx or publication of results of clinical trials in the form of papers

Publications

  • Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.

    PubMed 28391775

  • Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4.

    PubMed 28988646

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cardunilizumab in people with Sarcoma, Soft Tissue, run by Xiangya Hospital of Central South University 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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate，ORR (time frame: 24 months). 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 NCT06114173, which also lists 2 linked publications.

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 2 Nov 2023.

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