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OsteosarcomaEarly Phase 1NCT06117878

Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma

A Early Phase 1 study testing NK510 in people with Osteosarcoma and Soft Tissue Sarcoma, run by Base Therapeutics (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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study will evaluate the safety and efficacy of NK510 in the treatment of Osteosarcoma and Soft Tissue Sarcoma.NK510 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated. Read more about this study

Who is it for?
Ages 10 to 75 years
Conditions the study is for
Osteosarcoma, Soft Tissue Sarcoma
What is being tested?
NK510
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 Sep 2022to 1 Sep 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 10 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • signed informed consent obtained,can be followed upon protocol;
  • age ≥ 10 years;
  • histopathologically confirmed diagnosis of advanced metastatic osteosarcoma or non-specific soft tissue sarcoma;
  • Subjects for dose-escalation studies: failed to at least one chemotherapy regimen and undergoing disease progression or untolerable drug toxicity before enrollment;Subjects for postoperative adjuvant therapy study: radical surgery within 3 months before the first infusion of NK510 and no local recurrence or distant metastasis;
  • according to RECIST 1.1,Recurrent and refractory patients have at least one measurable lesion at baseline. Patients receiving adjuvant treatment after radical surgery have no measurable lesions on imaging examination;
  • ECOG physical status score of 0 or 1;
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  • Expected survival >=12 weeks;
  • Female subjects of childbearing age or male subjects whose sexual partners are female subjects of childbearing age are required to take effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period;
  • good organ and bone marrow hematopoietic function, the laboratory test values within 7 days before enrollment meet the following requirements (no medication for blood components, cell growth factors, or albumin correction treatment is allowed within the first 14 days of obtaining laboratory test), as follows:
  • Hematological:Neutrophil count ≥1.5×10^9/L; Platelet count ≥ 75×10^9/L; Hemoglobin ≥ 9 g/dL;
  • Hepatic:Total bilirubin ≤1.5 x ULN;ALT and AST≤2.5×ULN;Albumin ≥ 28 g/L; Alkaline phosphatase ≤ 5 × ULN;
  • Renal:Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 50mL/min (Cockcroft Fault formula);Patients whose urine routine results show urinary protein<2+or whose baseline urine routine test shows urinary protein ≥ 2+will undergo 24-hour urine collection with a 24-hour urine protein quantification of<1g.
  • Coagulation:International standardized ratio (INR) ≤ 2, and activated partial thromboplastin time ≤ 1.5 × ULN.

Who cannot join

  • Have received local or systemic anti-tumor treatment within 4 weeks before the first administration of NK510(Chinese medicine or traditional Chinese patent medicines and simple preparations is 2 weeks before administration);
  • Untreated active hepatitis B (HbsAg positive and peripheral blood HBV-DNA>1000 IU/ml); Hepatitis C virus antibody positive;
  • Patients with central nervous system metastasis;
  • Previous history of arterial and venous thromboembolism events, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolism within 6 month before NK510 first infusion;
  • Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy;
  • Uncontrolled hypertension, with systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg after optimal medical treatment, hypertension crisis or history of hypertensive encephalopathy;
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  • Symptomatic congestive heart failure (New York Heart Association classification II-IV). Symptomatic or poorly controlled arrhythmia. The QT interval is prolonged, with QTc>450ms for males and 470ms for females. The echocardiography shows that the left ventricular ejection fraction at rest is less than 50%;
  • Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within one year before the first study medication;
  • People infected with human immunodeficiency virus (HIV), known as active syphilis carriers;
  • Severe infections that are active or poorly controlled clinically. Severe infection within 4 weeks prior to initial administration, including but not limited to hospitalization due to complications such as infection, bacteremia, or severe pneumonia;
  • Administer therapeutic antibiotics orally or intravenously within one week before starting the study treatment;
  • Active autoimmune diseases requiring systemic treatment have occurred within 2 years prior to the first administration. Allow the use of alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency). A known history of primary immunodeficiency;
  • Within 4 weeks before the first administration, immunosuppressive drugs have been used, excluding local corticosteroids administered through nasal spray, inhalation, or other means, or systemic corticosteroids administered in physiological doses (i.e. no more than 10 mg/day of prednisone equivalent dose). Temporary use of corticosteroids is allowed for the prevention of allergic reactions or the treatment of respiratory distress symptoms such as asthma and chronic obstructive pulmonary disease;
  • Within 4 weeks before the first administration or planned to receive live attenuated vaccines during the study period;
  • Uncontrolled/uncorrectable metabolic disorders or other non malignant tumor organ diseases or systemic diseases or secondary reactions to cancer, which can lead to high medical risk and/or uncertainty in survival evaluation;
  • Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may lead to increased risk of study participation or drug administration, or interference with the interpretation of study results, based on the judgment of the investigator, the patient is not eligible to participate in this study;
  • Diagnosed as other malignant tumors within 5 years prior to the first administration, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection;
  • Those who have participated in clinical trials of other drugs and received treatment with investigational drugs within 4 weeks before the first administration;
  • Within 2 weeks before the first administration, medication with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural or ascites) has been received;
  • Pregnant or lactating female patients.

Trial locations and contacts

1 site in 1 country.

Jun Yan, PhD contact

+8618621668515

yanjun@basetherapeutics.com

Yingqi Hua, PhD contact

+86 138 1765 1474

hua_yingqi@163.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai

    Yingqi Hua, PhD, +86 138 1765 1474, hua_yingqi@163.com

    Recruiting

Other trials in China

About this study

Official title: An Open, Single Center Exploratory Study to Evaluate Safety and Efficacy of NK510 for Patients With Osteosarcoma and Soft Tissue Sarcoma

This study will evaluate the safety and efficacy of NK510 in the treatment of Osteosarcoma and Soft Tissue Sarcoma.NK510 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.

Being tested
NK510
Medical subject headings
Osteosarcoma, Sarcoma

What participants receive

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

  • NK510Drug

    NK510 will be administered through intravenous infusion.once a week，for a total of six times.

  • NK510Drug

    NK510 will be administered through intravenous infusion.Twice infusions on week 1,week 3,week 5 respectively.

Study groups in NCT06117878
Study groupRoleWhat they receive
Group A(low-dose group)ExperimentalNK510 1×10^9 NK cells/dose.
Receives: Drug: NK510
Group B(medium-dose group)ExperimentalNK510 3×10^9 NK cells/dose.
Receives: Drug: NK510
Group C(high-dose group)ExperimentalNK510 9×10^9 NK cells/dose.
Receives: Drug: NK510
Group D(high-dose group，postoperative adjuvant treatmen)ExperimentalNK510 9×10^9 NK cells/dose.
Receives: Drug: NK510

What is being measured

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

  1. Dose-Limiting Toxicity

    To evaluate the DLT during N510 treatment

    Measured: 6 weeks

  2. Maximal Tolerable Dose

    To evaluate the MTD of NK510

    Measured: 6 weeks

Secondary outcomes (1)

  1. Overall response rate (ORR)

    Effectiveness Metrics

    Measured: 6 weeks

Timeline

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

  1. First posted7 Nov 2023
  2. Study start1 Sep 2022
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 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
Non-randomised
Intervention model
Sequential
Model description
Dose escalation study
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06117878
Sponsor's protocol ID
NK510-05
Status last verified
Oct 2023
First submitted
31 Oct 2023
Last updated
7 Nov 2023
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 Early Phase 1 study testing NK510 in people with Osteosarcoma and Soft Tissue Sarcoma, run by Base Therapeutics (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 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 7 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?

Contact Jun Yan, PhD (+8618621668515, yanjun@basetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT06117878.

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 7 Nov 2023.

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