High-grade OsteosarcomaPhase 3NCT04359550
Study of ZKAB001 for Maintenance Therapy in Patients With High-grade Osteosarcoma After Adjuvant Chemotherapy
A Phase 3 study testing Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001) in people with High-grade Osteosarcoma, run by Lee's Pharmaceutical Limited.
Trial summary
It is a randomized, double-blind, placebo-controlled, multicenter study with the sample size is 362. The patients with high-grade osteosarcoma who had previously received surgery and completed adjuvant chemotherapy will be randomly assigned to ZKAB001 group (trial group) or placebo group (control group) according to… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- High-grade Osteosarcoma
- What is being tested?
- Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2023
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntarily participate in the trial and sign the informed consent form.
- Age ≥ 12 years old, both male and female.
- High-grade osteosarcoma diagnosed by histopathology (Ennecking stage II) ,radical surgery (R0 resection) and the adjuvant chemotherapy was confirmed by investigators. The end of adjuvant chemotherapy was no more than 12 weeks.
- Chemotherapy with more than two drugs must be used; the accumulated dose of doxorubicin should not be less than 300mg/m^2 (including converted dose); the total course of chemotherapy before and after operation should not be less than 12 times, the starting time of postoperative chemotherapy should not exceed 30 days, and the time of postoperative chemotherapy should not exceed 40 weeks.
- The score of the Eastern Cooperative Oncology Group (ECOG) is 0-1.
- The estimated survival time is more than 3 months.
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- The functions of important organs meet the following requirements;
- Absolute neutrophil count ≥ 1.5 × 10^9 / L.
- Platelet count ≥ 75 × 10^9 /L.
- Hemoglobin ≥ 90g/L.
- Serum albumin ≥ 28g/L.
- Total bilirubin ≤ 1.5 × ULN;ALT, AST ≤ 2.5 × ULN.
- Serum creatinine ≤ 1.25 × ULN or endogenous creatinine clearance ≥ 50mL/min (using standard Crockcroft-Gault formula).
- Thyroid function: thyroid stimulating hormone (TSH) is normal. If TSH is abnormal, free thyroxine（ FT3 and FT4 ）levels should be examined. Normal FT3 and FT4 levels can be enrolled.
- Female subjects of childbearing age should take effective contraceptive methods during the study period and within 3 months after the end of the study period, and the serum human chorionic gonadotropin pregnancy test (HCG) must be negative within 7 days before enrollment.
Who cannot join
- Local recurrence or distant metastasis;
- There is active autoimmune disease or history of autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, colitis, hepatitis, arthritis, glomerulonephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.), but does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones.
- Type I diabetes with stable doses of insulin;
- Vitiligo or cured childhood asthma / allergies in adults without medical intervention.
- The subjects were treated with immunosuppressants, or systemic or absorbable local corticosteroids with the purpose of immunosuppression (prednisone or equivalent for more than 10mg/ days), and continued to use them within 2 weeks before enrollment.
- Have received any form of organ transplantation, including allogeneic stem cell transplantation;
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- Previously known to be allergic to macromolecular protein preparations or to any ZKAB001 components;
- Previous or simultaneous suffering from other malignant tumors (except those that have been cured or cancer-free for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid, etc.);
- Uncontrolled cardiac clinical symptoms or diseases, such as heart failure above New York Heart Association(NYHA) 2, unstable angina pectoris, myocardial infarction within 1 year, clinical supraventricular or ventricular arrhythmias requiring intervention, echocardiography shows that the left ventricular ejection fraction at rest is less than 50%; - The completion of the treatment of radiotherapy, chemotherapy, surgery and/or molecular targeted therapy is less than 3 weeks before the first dose of study drug;
- Active infection (need to be treated with anti-bacterial, viral and/or fungal drugs), or fever of unknown origin occurred during the screening period and occurred within one week before the first dose (judged by the investigators, except the fever caused by tumor).
- Positive for human immunodeficiency virus (HIV); untreated active hepatitis B (hepatitis B surface antigen is positive and peripheral blood HBV-DNA titer ≥ 1000IU/ml or comply with local positive criteria) and/or hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the lower limit)
- Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or patients with active pulmonary tuberculosis infection within one year before entering the group, or patients with active pulmonary tuberculosis infection history more than one year ago but without formal treatment;
- Participating in other clinical studies, or less than 4 weeks from the end of the previous clinical study;
- Other systemic anti-tumor therapy may be received during the study period;
- Previously received other PD-1 and / or PD-L1, or CTLA-4 antibody therapy, or other drug therapy for immune receptor modulators;
- The live vaccine was vaccinated within 4 weeks before screening.
- Known history of psychotropic substance abuse, alcohol abuse or drug use;
- Pregnant or lactating women;
- Any mental state that hinders the understanding or provision of informed consent;
- The investigators consider that the patient had other factors that might lead to the termination of the study, such as other serious diseases or serious laboratory abnormalities or accompanied by other factors that would affect the safety of the subjects, or family or social factors that would affect the collection of data and samples.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter，Phase III Clinical Study of Recombinant Anti-PD-L1 Monoclonal Antibody (ZKAB001) for Maintenance Therapy in Patients With High-grade Osteosarcoma After Adjuvant Chemotherapy
It is a randomized, double-blind, placebo-controlled, multicenter study with the sample size is 362. The patients with high-grade osteosarcoma who had previously received surgery and completed adjuvant chemotherapy will be randomly assigned to ZKAB001 group (trial group) or placebo group (control group) according to 1:1. The purpose is to evaluate the efficacy and safety of ZKAB001 in maintenance therapy after adjuvant chemotherapy in patients with high-grade osteosarcoma.
Read the detailed description
The patients will be given ZKAB001 injection in 10mg/kg or placebo once every 3 weeks for a total of 16 cycles or 1 year. The end point is that the patient has been taking the drug for 16 cycles or 1 year, or the patient dies or develops intolerable toxicity or confirmed disease recurrence or distant metastasis or withdrawal of informed consent, whichever comes first.
In this study, after a screening period of no more than 28 days, qualified subjects will be given ZKAB001 or placebo and test visits. Imaging examination will be performed every 12 weeks after the first dose until the local or distant recurrence of the disease, or the initiation of other systematic anti-tumor therapy or death, whichever come first.
The survival follow-up period starts from the last treatment to a maximum of 4 years, or to the death or loss of follow-up or withdrawal of informed consent or the sponsor terminates the study every 3 months.
- Conditions
- High-grade Osteosarcoma
- Being tested
- Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)Biological
Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | ZKAB001 injection 10mg/kg once every 3 weeks for 1 cycle (Q3w), up to 16 cycles or 1 year of treatment. Receives: Biological: Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001) |
| control group | Placebo comparator | placebo will given in the same way for once every 3 weeks for 1 cycle (Q3w), up to 16 cycles or 1 year of treatment. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year DFS rate
The percentage of patients with no recurrence or metastasis within one year
Measured: 1 year
Secondary outcomes (4)
Five-years OS rate
Patients who survive within 5 years after the first dose.
Measured: 5 years
adverse events
Incidence and severity of adverse events
Measured: 5 years
Immunogenecity of ZKAB001
To evaluated the number of subjects presenting detectable anti drug antibodies (ADAs).
Measured: 1 year
PD-L1 expression
Correlation between PD-L1 expression level and clinical efficacy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359550
- Sponsor's protocol ID
- NTL-LEES-2019-08
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter，Phase III Clinical Study of Recombinant Anti-PD-L1 Monoclonal Antibody (ZKAB001) for Maintenance Therapy in Patients With High-grade Osteosarcoma After Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04359550
- Acronym / sponsor ID
- NTL-LEES-2019-08
- Conditions
- High-grade Osteosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a randomized, double-blind, placebo-controlled, multicenter study with the sample size is 362. The patients with high-grade osteosarcoma who had previously received surgery and completed adjuvant chemotherapy will be randomly assigned to ZKAB001 group (trial group) or placebo group (control group) according to 1:1. The purpose is to evaluate the efficacy and safety of ZKAB001 in maintenance therapy after adjuvant chemotherapy in patients with high-grade osteosarcoma.
Detailed description
The patients will be given ZKAB001 injection in 10mg/kg or placebo once every 3 weeks for a total of 16 cycles or 1 year. The end point is that the patient has been taking the drug for 16 cycles or 1 year, or the patient dies or develops intolerable toxicity or confirmed disease recurrence or distant metastasis or withdrawal of informed consent, whichever comes first.
In this study, after a screening period of no more than 28 days, qualified subjects will be given ZKAB001 or placebo and test visits. Imaging examination will be performed every 12 weeks after the first dose until the local or distant recurrence of the disease, or the initiation of other systematic anti-tumor therapy or death, whichever come first.
The survival follow-up period starts from the last treatment to a maximum of 4 years, or to the death or loss of follow-up or withdrawal of informed consent or the sponsor terminates the study every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Biological: Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)ZKAB001 injection 10mg/kg once every 3 weeks for 1 cycle (Q3w), up to 16 cycles or 1 year of treatment. |
| control group | Placebo comparator | Other: placeboplacebo will given in the same way for once every 3 weeks for 1 cycle (Q3w), up to 16 cycles or 1 year of treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntarily participate in the trial and sign the informed consent form.
- Age ≥ 12 years old, both male and female.
- High-grade osteosarcoma diagnosed by histopathology (Ennecking stage II) ,radical surgery (R0 resection) and the adjuvant chemotherapy was confirmed by investigators. The end of adjuvant chemotherapy was no more than 12 weeks.
- Chemotherapy with more than two drugs must be used; the accumulated dose of doxorubicin should not be less than 300mg/m^2 (including converted dose); the total course of chemotherapy before and after operation should not be less than 12 times, the starting time of postoperative chemotherapy should not exceed 30 days, and the time of postoperative chemotherapy should not exceed 40 weeks.
- The score of the Eastern Cooperative Oncology Group (ECOG) is 0-1.
Key exclusion criteria (20 listed)
- Local recurrence or distant metastasis;
- There is active autoimmune disease or history of autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, colitis, hepatitis, arthritis, glomerulonephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.), but does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones.
- Type I diabetes with stable doses of insulin;
- Vitiligo or cured childhood asthma / allergies in adults without medical intervention.
- The subjects were treated with immunosuppressants, or systemic or absorbable local corticosteroids with the purpose of immunosuppression (prednisone or equivalent for more than 10mg/ days), and continued to use them within 2 weeks before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001) | Biological | treatment group |
| placeboplacebo | Other | control group |
Primary outcome
One-year DFS rate
Time frame: 1 year
The percentage of patients with no recurrence or metastasis within one year
4 secondary outcomes
Five-years OS rate
Time frame: 5 years
adverse events
Time frame: 5 years
Immunogenecity of ZKAB001
Time frame: 1 year
PD-L1 expression
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001) in people with High-grade Osteosarcoma, run by Lee's Pharmaceutical Limited.
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 15 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yang Yao, Master (18930177737, yangyao_6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year DFS rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.