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Sarcoma, Soft TissuePhase 2NCT05193214

A Phase II Study for 609A in the Treatment of Advanced Undifferentiated Pleomorphic Sarcoma

A Phase 2 study testing Recombinant anti-PD-1 humanized monoclonal antibody injection in people with Sarcoma, Soft Tissue, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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 main purpose of this study is to evaluate the efficacy and safety of recombinant anti-PD-1 humanized monoclonal antibody injection (609A) in patients with unresectable or advanced undifferentiated pleomorphic sarcoma 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?
Recombinant anti-PD-1 humanized monoclonal antibody injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
25 Jan 2022to 31 Dec 2024
Phase
Phase 2
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

  • A Chinese citizen who understands and is willing to sign an informed consent form (ICF).
  • Age ≥18 years old and ≤75 years old, regardless of gender.
  • For patients with unresectable or advanced undifferentiated pleomorphic sarcoma confirmed by cytology or histopathology, the subject is willing to provide a sufficient number of tumor tissue sections for pathological type confirmation in the central pathology room.
  • At least one anthracycline-containing chemotherapy regimen failed (disease progression or intolerable toxicity).
  • There is at least one measurable lesion (see RECIST 1.1 standard for definition).
  • The Eastern Cooperative Oncology Group (ECOG) score 0-1 points.
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  • Life expectancy ≥ 3 months.
  • The pregnancy test of female patients with fertility is negative within 3 days before the first administration; any male and female patients with fertility must agree to use medical approval during the entire trial period and within 6 months after the last trial drug is administered. Method of contraception.
  • Before 609A starts treatment, it must have sufficient organ functions, including: a) Bone marrow reserve: absolute neutrophil (ANC) ≥1.0×10^9/L; platelet count ≥90×10^9/L; Hemoglobin ≥90g/L or ≥5.6mmol/L; b) Total bilirubin≤1.5×ULN, AST and/or ALT≤3×ULN (if abnormal liver function is caused by tumor liver metastasis, then AST and/or ALT≤5×ULN); c) Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50mL/min (Cockroft and Gault formula); d) Coagulation test international normalized ratio (INR) ≤2 (except: warfarin anticoagulation The treated patients can receive INR 2 to ≤3), and activated partial thromboplastin time (APTT) ≤1.5×ULN.

Who cannot join

  • Known to be allergic to protein drugs or recombinant proteins or excipients in 609A pharmaceutical preparations, or have severe allergic reactions after administration of other monoclonal antibodies, or have a history of life-threatening allergies.
  • Have received any of the following anti-tumor treatments in the past: a) Have received any anti-tumor treatment within 4 weeks before the first administration, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, hormone therapy (hormone replacement therapy, testosterone or (Except for oral contraceptives), biological therapy and anti-tumor Chinese medicine treatment, etc.; b) Have received immunoagonist treatment within 4 weeks before the first administration; c) Have previously received immunotherapy for T cell co-stimulation or checkpoint approach.
  • According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, any residual AE from previous anti-tumor therapy did not return to grade 0 or 1, or did not meet other selections/exclusions other than this one The level specified in the standard, except for residual hair loss effects.
  • Have received other drug clinical trial treatment or interventional device clinical trial treatment within 4 weeks before the first administration.
  • Underwent major surgery within 21 days before the first administration.
  • Live attenuated vaccine was vaccinated within 28 days before the first dose.
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  • Use of leukocyte-promoting factors such as granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within 72 hours before the first administration, or 2 weeks before the first administration Have used erythropoietin (EPO) or suspended red blood cell transfusion, or have taken corrective measures such as platelet transfusion within 1 week before the first administration.
  • Subjects with central nervous system (CNS) metastasis.
  • Suffer from other active malignant tumors within 5 years or at the same time. Excludes cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.
  • A history of any type of primary immunodeficiency, a history of stem cell or organ transplantation.
  • Subjects with a history of active autoimmune diseases or autoimmune diseases, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Green- Barre syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, hepatitis, toxic epidermal necrolysis ( TEN), Stevens-Johnson syndrome (SJS) or antiphospholipid syndrome.
  • Patients who need to be treated with glucocorticoid (>15mg/d prednisone or equivalent dose of hormone) or other immunosuppressive agents within 14 days before the first administration of the planned trial drug. In the absence of active autoimmune diseases, inhaled or topical glucocorticoids can be used. Hormone replacement therapy doses ≤ 10 mg/d prednisone equivalent are acceptable. Accepts ophthalmology, nasal cavity and intra-articular injection of glucocorticoids.
  • There are clinically important cardiovascular and cerebrovascular diseases, including: a) Severe or uncontrollable heart disease that requires treatment, congestive heart failure The New York Heart Association (NYHA) is classified as III or IV, and drugs cannot be controlled. Stable angina pectoris, history of myocardial infarction in the past 6 months, QTc interval of electrocardiogram: male ≥450 milliseconds, female ≥470 milliseconds, severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia) . b) Patients with indwelling heart stent within 6 months. c) Insufficient control of hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg.
  • People with a history of interstitial lung disease, idiopathic pulmonary fibrosis, unresolved active or chronic inflammatory lung disease cannot be included in the group. Subjects who have radiation pneumonia but have recovered can be included in the group;
  • People with any of the following infections: a) Active hepatitis B or C. Hepatitis B virus (HBV) carriers without active disease or cured hepatitis C can be included in the group; b) Human immunodeficiency virus (HIV) infection; c) Severe chronic or active infection, requiring systemic antibacterial, antifungal or antibacterial Viral therapy, including active tuberculosis infection, etc.; d) Febrile neutropenia or unexplained single fever> 38.5°C within 1 week before the first administration of the test drug The fever generated by the tumor can be included in the group).
  • Any other serious illnesses (for example: uncontrolled diabetes, active gastric ulcer, uncontrolled epilepsy, cerebrovascular events, gastrointestinal bleeding, coagulopathy with severe symptoms and signs), mental, psychological, Family or geographic conditions, based on the judgment of the investigator, may interfere with trial planning, treatment, and follow-up, or affect the subject's compliance, or put the subject at high risk of treatment-related complications.
  • Women who are pregnant or breastfeeding.
  • Any other situation where the investigator judges that the patient is not suitable for entry into this trial.

Trial locations and contacts

1 site in 1 country.

Gang Tong, MD contact

021-60970099

tonggang@3sbio.com

China1 site

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035

    Xiaohui Niu, Master, 010-58516688 ext. 6436, niuxiaohui@263.net

Other trials in China

About this study

Official title: An Open Label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (609A) in Patients With Unresectable or Advanced Undifferentiated Pleomorphic Sarcoma

The main purpose of this study is to evaluate the efficacy and safety of recombinant anti-PD-1 humanized monoclonal antibody injection (609A) in patients with unresectable or advanced undifferentiated pleomorphic sarcoma

Read the detailed description

This is a multi-center, open label, phase II clinical study. The safety and effectiveness of 609A in the treatment of unresectable or advanced undifferentiated pleomorphic sarcoma are mainly evaluated by ORR (based on the results of CT/MRI examination of subjects during treatment).

Being tested
Recombinant anti-PD-1 humanized monoclonal antibody injection
Keywords
Sarcoma, Soft Tissue, 609A
Medical subject headings
Sarcoma

What participants receive

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

  • Recombinant anti-PD-1 humanized monoclonal antibody injectionDrug

    Also called 609A

    Each subject received 609A 200 mg intravenous infusion, once every 3 weeks (Q3W), until disease progression, intolerable toxicity, death, informed withdrawal, early withdrawal from the study, loss to follow-up, or the end of the study, whichever occurs first Whichever prevails.

Study groups in NCT05193214
Study groupRoleWhat they receive
609A UPSExperimentalThe 609A single-drug regimen (200mg Q3W) was used to treat unresectable or advanced undifferentiated pleomorphic sarcoma to evaluate the safety and effectiveness of 609A.
Receives: Drug: Recombinant anti-PD-1 humanized monoclonal antibody injection

What is being measured

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

  1. ORR,Objective response rate

    CT/MRI examinations were performed every 6 weeks, and the efficacy of anti-tumor treatment was evaluated by RECEIST and iRECEIST standards.

    Measured: up to 18 months.

Secondary outcomes (7)

  1. AE

    All adverse events related to 609A observed through various tests (including blood routine, pregnancy test, electrocardiogram, etc.)

    Measured: up to 18 months.

  2. BOR, Best overall response

    CT/MRI examinations were performed every 6 weeks, and the efficacy of anti-tumor treatment was evaluated by RECEIST and iRECEIST standards.

    Measured: up to 18 months.

  3. DCR, Disease control rate

    CT/MRI examinations were performed every 6 weeks, and the efficacy of anti-tumor treatment was evaluated by RECEIST and iRECEIST standards.

    Measured: up to 18 months.

  4. DOR, Duration of Response

    CT/MRI examinations were performed every 6 weeks, and the efficacy of anti-tumor treatment was evaluated by RECEIST and iRECEIST standards.

    Measured: up to 18 months.

  5. TTR, Time to response

    CT/MRI examinations were performed every 6 weeks, and the efficacy of anti-tumor treatment was evaluated by RECEIST and iRECEIST standards.

    Measured: up to 18 months.

  6. SD duration

    CT/MRI examinations were performed every 6 weeks, and the efficacy of anti-tumor treatment was evaluated by RECEIST and iRECEIST standards.

    Measured: up to 18 months.

  7. Immunogenicity of 609A

    Detect the presence of anti-609A antibodies through the subject's blood sample

    Measured: up to 18 months.

Timeline

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

  1. First posted14 Jan 2022
  2. Study start25 Jan 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05193214
Sponsor's protocol ID
SSGJ-609-UPS-II-01
Status last verified
Dec 2021
First submitted
31 Dec 2021
Last updated
14 Jan 2022
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 Recombinant anti-PD-1 humanized monoclonal antibody injection in people with Sarcoma, Soft Tissue, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. 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 9 inclusion and 18 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 14 Jan 2022. 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?

Results are not available in the source record.

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

Contact Gang Tong, MD (021-60970099, tonggang@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR,Objective response rate (time frame: up to 18 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 NCT05193214.

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 14 Jan 2022.

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