Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma

NCT06114173 | Unknown Early Phase 1

• 1 other identifier: 202303215
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (1)

• Objective response rate，ORR

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

  24 months

Secondary Outcomes (4)

• Incidence of adverse events

  24 months

• Incidence of immune-related adverse events

  24 months

• overall survival,OS

  24 months

• progression-free survival,PFS

  24 months

Other Outcomes (1)

• PD-L1 immunohistochemical assay values

  24MONTHS

Study Arms (1)

drug-dosing group

EXPERIMENTAL

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

Drug: Cardunilizumab

Interventions

Cardunilizumab DRUG

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

Also known as: PD-1/CTLA-4 Bispecific Antibody

drug-dosing group

Eligibility Criteria

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

You may qualify if:

• agree to sign the informed consent form.
• 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.
• 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:
• a) 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.
• d) 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Related Publications (2)

• 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.

  PMID: 28391775 RESULT

• 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.

  PMID: 28988646 RESULT

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• bin Li, doctor

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)