Advanced Malignant TumorsPhase 1NCT05877924
A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
A Phase 1 study testing NBL-020 for Injection in people with Advanced Malignant Tumors, run by NovaRock Biotherapeutics, Ltd at 1 site in China.
Trial summary
This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- NBL-020 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are 18 years old or older (based on the date of signing the informed consent form) and voluntarily sign the informed consent form;
- For malignant tumors confirmed by histology or cytology, only solid tumor subjects were included in dose escalation study. In addition to solid tumors, additional skin T-cell lymphoma subjects could be considered in dose expansion study;
- Must be willing to provide tumor tissue samples that can meet the requirements of biomarker testing (fresh biopsy tissue is preferred; if fresh tissue cannot be provided, tumor tissue samples within 2 years can be provided), and tumor samples will be tested by the central laboratory. If tumor tissue does not meet the testing requirements, additional biopsy may be required;
- If the standard treatment fails or toxicity is intolerable, or there is no standard treatment, the enrolled subjects must fully recover from previous treatment, with an AE level of 0-1 (except for alopecia, pigmentation, or other toxicity that the researcher believes is not a safety risk to the subjects);
- For subjects with solid tumor, there is at least one measurable lesion that meets the RECIST 1.1 standard at the baseline (the measurable lesion area has not received radiotherapy in the past, or there is evidence that the lesion has unequivocal progressed after radiotherapy);
- ECOG PS score 0-1 points;
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- Expected survival time ≥ 3 months (12 weeks);
- Good organ function (no blood transfusion or growth factor support treatment received within 2 weeks before blood collection for relevant examinations), including:
- Absolute value of neutrophils (ANC) ≥ 1.5 × 10^9/L；
- Hemoglobin (Hb) ≥ 90 g/L;
- Platelets ≥ 100 × 10^9 /L;
- Creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥ 50 mL/min (Cockcroft Fault formula);
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome）;
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver metastasis);
- Coagulation function: activated partial thromboplastin time(APTT), international standardized ratio (INR) ≤ 1.5 × ULN.
- Note: If the subject does not meet the requirements during screening, a re-examination is allowed.
- The subjects must agree to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last administration. Women of childbearing age tested negative for serum pregnancy within 7 days before the first dose of the investigational drug.
Who cannot join
- Subjects with a history of severe allergies to monoclonal antibodies;
- Active pia mater lesions or uncontrolled brain metastases exist. Subjects with suspected or confirmed brain metastasis can be enrolled as long as they are asymptomatic and do not require treatment (such as radiotherapy, surgery, or corticosteroid therapy) to control the symptoms of brain metastasis. For subjects with brain metastasis requiring treatment, their symptoms remain stable (without hormone maintenance treatment, without symptoms of brain metastasis) for 2 weeks after treatment, and they can be enrolled.
- Subjects with active autoimmune diseases or a history of autoimmune diseases, but with the following diseases are allowed to be included in the study: well controlled type I diabetes, well controlled hypothyroidism only requiring hormone replacement treatment, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects who are expected to have no relapse under the condition of no external trigger factors;
- Having a history of primary immunodeficiency, a history of allogeneic organ transplantation, or a history of allogeneic hematopoietic stem cell transplantation;
- Chronic hepatitis B (HBsAg and/or HBcAb positive but HBV DNA<2000 IU/mL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive;
- The toxicity of previous anti-tumor treatments has not returned to ≤ Grade 1 (except for alopecia, pigmentation, or other toxicity that the researchers believe is not a safety risk to the subjects);
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- Have a history of serious cardiovascular disease, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, including but not limited to ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, within 6 months prior to the first dose of the investigational drug;
- Have a history of myocardial infarction, unstable angina, angioplasty, or coronary artery bypass surgery within 6 months before the first dose of the experimental drug;
- Heart failure, classified as Grade Ш or above by the New York Heart Association (NYHA);
- Subjects with prolonged QT/QTc interval in the screening period electrocardiogram);
- During the screening, echocardiography showed left ventricular ejection fraction (LVEF)<50%;
- Poor control of hypertension (screening period systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- Uncontrollable serous cavity effusion that requires frequent drainage or medical intervention (such as pleural effusion, abdominal effusion, pericardial effusion, etc., which requires additional intervention within 2 weeks after the intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the experimental drug;
- Severe or active infections (including tuberculosis infections) that require systemic antibacterial, antifungal, or antiviral treatment within 14 days before the first use of the experimental drug, except for subjects with viral hepatitis receiving antiviral treatment;
- Received any anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) and any clinical research treatment within 4 weeks or 5 half-lives before the first administration (whichever is shorter);
- Have a history of (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment, or currently have (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment.
- Subjects are required to receive systemic corticosteroids (>10 mg daily prednisone or equivalent) or immunosuppressive therapy within 14 days before the first dose. Inhalation or local application of corticosteroids, adrenal hormone replacement therapy, and short-term (≤ 7 days) use of corticosteroids to prevent contrast agent allergies are allowed.
- History of immune related adverse events (immune-related AE) ≥ Grade 3 (CTCAE 5.0) after receiving immunotherapy;
- Previously received targeted TNFR2 treatment;
- Those who have undergone major surgery within 4 weeks before the first administration and have not yet fully recovered, or plan to undergo major surgery during the study period;
- Previous malignancies other than the disease under study within 3 years, except for those that can be cured through local treatment, such as skin basal cell carcinoma, cervical or breast cancer in situ;
- Pregnant or lactating women;
- Participate in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or during the follow-up period of an intervention study;
- Has a clear history of neurological or mental disorders, including epilepsy or dementia;
- Other circumstances that researchers believe not suitable to participate in clinical trials, including but not limited to: subjects with severe or uncontrollable medical conditions, safety risks, interference with the interpretation of research results, and impact on trial compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wu Yilong
Guanzhou, Guangdong
Yilong Wu, 021-38804518-22132, syylwu@live.cn
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Activity of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.
Read the detailed description
The study is divided into two parts: dose escalation and dose expansion. Dose increasing study: The initial dose for the dose escalation study is 0.1 mg/kg administered once every 3 weeks (Q3W), with a pre-set maximum escalation dose of 30 mg/kg Q3W. Safety Management Committee (SMC) can jointly discuss and determine whether to proceed with a higher dose group or increase additional doses or different dosing intervals between two adjacent dose groups (such as Q2W or Q4W) based on the safety, tolerance, efficacy, PK, PD, and related biomarker data of each dose group.
Dose expansion study: Based on the results of the dose escalation study, the dosage for the dose extension study will be determined through joint discussion between the sponsor and the investigators. If necessary, multiple doses can be selected for dose extension.
- Conditions
- Advanced Malignant Tumors
- Being tested
- NBL-020 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBL-020 for InjectionDrug
NBL-020 for Injection, Q3W, i.v.
| Study group | Role | What they receive |
|---|---|---|
| NBL-020 | Experimental | Dose increasing study: The initial dose for the dose escalation study is 0.1 mg/kg administered once every 3 weeks (Q3W), with a pre-set maximum escalation dose of 30 mg/kg Q3W.
Dose expansion study: Based on the results of the dose escalation study, the dosage for the dose extension study will be determined through joint discussion between the sponsor and the investigators. Receives: Drug: NBL-020 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of all adverse events (AEs) and severe adverse events (SAEs).
adverse events (AEs) and severe adverse events (SAEs)
Measured: From the first administration to 30 days after the end of the last administration, up to approximately 2 years
Secondary outcomes (14)
Cmax
Observed maximum concentration
Measured: 14 days
AUC0-t
AUC0-t
Measured: 14 days
AUC0-inf
AUC0-inf
Measured: 14 days
Tmax
Time to maximum concentration
Measured: 14 days
t1/2
Apparent terminal Half-Life
Measured: 14 days
Vz
Vz
Measured: 14 days
ORR
Objective response rate
Measured: Up to approximately 2 years.
DCR
Disease control rate
Measured: Up to approximately 2 years.
PFS
Progression free survival
Measured: Up to approximately 2 years.
DOR
Duration of response
Measured: Up to approximately 2 years.
OS
Overall survival
Measured: Up to approximately 2 years.
Anti NBL-020 antibody (ADA) and neutralizing antibody (Nab).
Anti NBL-020 antibody and neutralizing antibody.
Measured: 14 days
NBL-020 receptor occupancy rate for tumor necrosis factor type Ⅱ receptor (TNFR2).
NBL-020 receptor occupancy rate for tumor necrosis factor type Ⅱ receptor.
Measured: 14 days
Concentration of free tumor necrosis factor type Ⅱ receptor (TNFR2).
Concentration of free tumor necrosis factor type Ⅱ receptor.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaRock Biotherapeutics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Principal investigator, Guangdong Provincial People's Hospital, Guangzhou City, Guangdong Province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877924
- Sponsor's protocol ID
- NBL-020-001
- Status last verified
- Aug 2023
- First submitted
- 18 May 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Activity of NBL-020 Injection in Subjects With Advanced Malignant Tumors.
- ClinicalTrials.gov ID
- NCT05877924
- Acronym / sponsor ID
- NBL-020-001
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NovaRock Biotherapeutics, LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 May 2023 (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.
This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.
Detailed description
The study is divided into two parts: dose escalation and dose expansion. Dose increasing study: The initial dose for the dose escalation study is 0.1 mg/kg administered once every 3 weeks (Q3W), with a pre-set maximum escalation dose of 30 mg/kg Q3W. Safety Management Committee (SMC) can jointly discuss and determine whether to proceed with a higher dose group or increase additional doses or different dosing intervals between two adjacent dose groups (such as Q2W or Q4W) based on the safety, tolerance, efficacy, PK, PD, and related biomarker data of each dose group.
Dose expansion study: Based on the results of the dose escalation study, the dosage for the dose extension study will be determined through joint discussion between the sponsor and the investigators. If necessary, multiple doses can be selected for dose extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBL-020 | Experimental | Drug: NBL-020 for InjectionDose increasing study: The initial dose for the dose escalation study is 0.1 mg/kg administered once every 3 weeks (Q3W), with a pre-set maximum escalation dose of 30 mg/kg Q3W. Dose expansion study: Based on the results of the dose escalation study, the dosage for the dose extension study will be determined through joint discussion between the sponsor and the investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Those who are 18 years old or older (based on the date of signing the informed consent form) and voluntarily sign the informed consent form;
- For malignant tumors confirmed by histology or cytology, only solid tumor subjects were included in dose escalation study. In addition to solid tumors, additional skin T-cell lymphoma subjects could be considered in dose expansion study;
- Must be willing to provide tumor tissue samples that can meet the requirements of biomarker testing (fresh biopsy tissue is preferred; if fresh tissue cannot be provided, tumor tissue samples within 2 years can be provided), and tumor samples will be tested by the central laboratory. If tumor tissue does not meet the testing requirements, additional biopsy may be required;
- If the standard treatment fails or toxicity is intolerable, or there is no standard treatment, the enrolled subjects must fully recover from previous treatment, with an AE level of 0-1 (except for alopecia, pigmentation, or other toxicity that the researcher believes is not a safety risk to the subjects);
- For subjects with solid tumor, there is at least one measurable lesion that meets the RECIST 1.1 standard at the baseline (the measurable lesion area has not received radiotherapy in the past, or there is evidence that the lesion has unequivocal progressed after radiotherapy);
Key exclusion criteria (26 listed)
- Subjects with a history of severe allergies to monoclonal antibodies;
- Active pia mater lesions or uncontrolled brain metastases exist. Subjects with suspected or confirmed brain metastasis can be enrolled as long as they are asymptomatic and do not require treatment (such as radiotherapy, surgery, or corticosteroid therapy) to control the symptoms of brain metastasis. For subjects with brain metastasis requiring treatment, their symptoms remain stable (without hormone maintenance treatment, without symptoms of brain metastasis) for 2 weeks after treatment, and they can be enrolled.
- Subjects with active autoimmune diseases or a history of autoimmune diseases, but with the following diseases are allowed to be included in the study: well controlled type I diabetes, well controlled hypothyroidism only requiring hormone replacement treatment, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects who are expected to have no relapse under the condition of no external trigger factors;
- Having a history of primary immunodeficiency, a history of allogeneic organ transplantation, or a history of allogeneic hematopoietic stem cell transplantation;
- Chronic hepatitis B (HBsAg and/or HBcAb positive but HBV DNA<2000 IU/mL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive;
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 |
|---|---|---|
| NBL-020 for InjectionNBL-020 for Injection, Q3W, i.v. | Drug | NBL-020 |
Primary outcome
The occurrence of all adverse events (AEs) and severe adverse events (SAEs).
Time frame: From the first administration to 30 days after the end of the last administration, up to approximately 2 years
adverse events (AEs) and severe adverse events (SAEs)
14 secondary outcomes
Cmax
Time frame: 14 days
AUC0-t
Time frame: 14 days
AUC0-inf
Time frame: 14 days
Tmax
Time frame: 14 days
t1/2
Time frame: 14 days
Vz
Time frame: 14 days
ORR
Time frame: Up to approximately 2 years.
DCR
Time frame: Up to approximately 2 years.
PFS
Time frame: Up to approximately 2 years.
DOR
Time frame: Up to approximately 2 years.
OS
Time frame: Up to approximately 2 years.
Anti NBL-020 antibody (ADA) and neutralizing antibody (Nab).
Time frame: 14 days
NBL-020 receptor occupancy rate for tumor necrosis factor type Ⅱ receptor (TNFR2).
Time frame: 14 days
Concentration of free tumor necrosis factor type Ⅱ receptor (TNFR2).
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Yilong Wu principal investigator
Guangdong Provincial People's Hospital, Guangzhou City, Guangdong Province, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NBL-020 for Injection in people with Advanced Malignant Tumors, run by NovaRock Biotherapeutics, 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 17 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 26 Mar 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilong Wu (021-38804518-22132, Syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of all adverse events (AEs) and severe adverse events (SAEs). (time frame: From the first administration to 30 days after the end of the last administration, up to approximately 2 years). 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 26 Mar 2024.