Advanced Solid TumorsPhase 1NCT05153096
Evaluation of the Safety and Efficacy of NBL-015 in Patients With Advanced Solid Tumors
A Phase 1 study testing NBL-015 in people with Advanced Solid Tumors, run by NovaRock Biotherapeutics, Ltd at 1 site in China.
Trial summary
This trial is an open-label, multicenter, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of NBL-015 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- NBL-015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- Apr 2022to Dec 2025
- Phase
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, ≤75 years, (subject to the date of signing the informed consent) who voluntarily sign the informed consent.
- Positive expression of Claudin 18.2 which is defined as moderate to severe membrane staining (2+/3+) in ≥50% of tumor cells tested by central laboratory immunohistochemistry (IHC).
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors.
- At least one measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Life expectancy ≥12 weeks.
- Adequate major organ function within 7 days prior to treatment.
- Serum pregnancy tests were negative in women of reproductive age (WOCBP) within 7 days prior to initial use of the investigational drug. Patients and their spouses must agree to take adequate contraceptive measures from the time of signing the informed consent until 6 months after the last dose. During this period, women are not breastfeeding and men avoid sperm donation.
Who cannot join
- A history of other malignancies within 3 years prior to first dose, except for locally curable cancers.
- Patients with central nervous system metastases.
- Gastrointestinal abnormalities include:
- Pyloric obstruction or persistent recurrent vomiting (defined as ≥3 times of vomiting in 24 hours); B) There is a high risk of gastrointestinal bleeding or that there are other gastrointestinal abnormalities affecting the drug toxicity assessment determined by the investigator.
- Patient with a history of serious cardiovascular disease.
- A history of severe autoimmune disease that the investigator judged inappropriate for inclusion.
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- Patients with active hepatitis B or C, or active syphilis infection, or HIV positive.
- Patients who are known to have severe allergic reactions and/or contraindications to prescription ingredients of NPL-015 or monoclonal antibodies, or who are intolerant to combination drugs;
- Patients who underwent major surgery (excluding needle biopsy) within 4 weeks prior to initial use of the investigational drug, or who required elective surgery during the trial period, or who had severe unhealed wounds, traumatic ulcers, etc.
- Toxicity of previous antitumor therapy did not return to grade 1 or below (CTCAE V5.0), except for toxicity of alopecia and other toxicity that researchers judged to have no safety risk.
- Patients have previously been treated with a drug targeting Claudin18.2.
- The time interval between the last anti-tumor treatment and the first use of experimental drug should meet the following requirements:
- Received antitumor therapy such as chemotherapy, radiotherapy (except local radiation therapy for pain relief), targeted therapy, immunotherapy, and other investigational agents within 4 weeks prior to initial administration; B) Received oral fluorouracil, small-molecule targeted drugs and traditional Chinese medicine with anti-tumor indications within 2 weeks prior to initial administration.
- Receiving a corticosteroid (prednisone>10 mg/ day or equivalent dose of the same kind of drug) or other immunosuppressant treatment, except for:
- Local, ocular, intraarticular, intranasal, and inhaled glucocorticoids; B) Short-term use of glucocorticoids for prophylactic treatment (e.g. to prevent contrast allergy).
- Live attenuated vaccine is received within 2 weeks prior to the first use of the investigational drug or is planned for the study period.
- Other conditions that the investigator considers inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, +86-021-64041990, liu.tianshu@zs-hospital.sh.cn
About this study
Official title: A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of NBL-015 in Patients With Advanced Solid Tumors
This trial is an open-label, multicenter, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of NBL-015 in patients with advanced solid tumors.
Read the detailed description
This study is a multicenter, open-label phase I clinical trial conducted in patients with CLDN18.2-positive advanced solid tumors, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of NBL-015 in patient with advanced solid tumors.
This study consists of two stages: the stage I (dose escalation and dose expansion) and the stage II (NBL-015 monotherapy cohort expansion and combination of NBL-015 with standard treatment cohort expansion).
The dose escalation phase is divided into 5 dose levels. NBL-015 is escalated in order of 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg until MTD. If MTD is still not observed in the preset highest dose group, the investigator and the sponsor can jointly decide whether to conduct a higher dose group study. If necessary, intermediate doses may be conducted. The first dose group (1 mg/kg) is the accelerated titration group, in which 1 patient will be enrolled, and the "3+3" dose escalation design will be followed from the second dose group.
If RP2D can be determined based on clinical study data in the dose escalation stage, Stage II cohort expansion will be directly conducted. Alternatively, based on the safety, tolerability and efficacy data obtained from dose-escalation studies, dose expansion and different dosing can be explored if necessary.
Based on available PK and clinical efficacy data, appropriate dose groups will be selected for cohort expansion. The cohort expansion stage includes the NBL-015 monotherapy cohort expansion trial and the combination of NBL-015with standard treatment cohort expansion trial.
- Conditions
- Advanced Solid Tumors
- Being tested
- NBL-015
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBL-015Drug
NBL-015 by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental: solid tumors | Experimental | Dose-escalation stage: Patients will receive NBL-015 once every two or three weeks, starting at a dose of 1 mg/kg.
Cohort-expansion stage: Patients will receive NBL-015 at selected dose as per the results of dose-escalation stage. Receives: Drug: NBL-015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) of single and multiple dose (according to NCI CTCAE 5.0).An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Approximately 4 years
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) of single and multiple dose (according to NCI CTCAE 5.0).
Measured: Approximately 4 years
Maximum tolerated dose (MTD) (if available)
MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities.
Measured: Approximately 1 year
Dose Limiting Toxicity (DLT )
Dose-limiting toxicity in patients with advanced tumors treated by NBL-015.
Measured: Up to 28 days after first injection
Recommended Phase 2 dose (RP2D)
RP2D will be determined using available safety and efficacy data.
Measured: Approximately 2 years
Objective response rate (ORR) (in stage Ⅱ)
Percentage of participants with CR or PR.
Measured: Approximately 2 years in stage Ⅱ
Disease control rate (DCR) (in stage Ⅱ)
Percentage of participants with CR or PR or SD.
Measured: Approximately 2 years in stage Ⅱ
Duration of response (DOR) (in stage Ⅱ)
DOR is defined as the time from first objective response (CR or PR per RECIST v 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v 1.1) or death from any cause, whichever occurs first.
Measured: Approximately 2 years in stage Ⅱ
Progression-free survival (PFS) (in stage Ⅱ)
PFS is defined as the time from first dose to the first observation of disease progression (based on central reading) or death from any cause (as assessed by the independent reviewer).
Measured: Approximately 2 years in stage Ⅱ
Overall survival (OS) (in stage Ⅱ)
OS is defined as the time from first dose to death from any cause.
Measured: Approximately 2 years in stage Ⅱ
Secondary outcomes (17)
Pharmacokinetic (PK)
Maximum plasma drug concentration (Cmax)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Area under the concentration time curve from 0 to time t (AUC0-t)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Area under the concentration time curve from 0 to the last measurable point (AUClast)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Area under the concentration time curve from 0 to infinity (AUC0-inf)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time to maximum concentration (Tmax)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Elimination half-life (t1/2)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Volume of Distribution During the Terminal Phase (Vz)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Clearance (CL)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Terminal elimination rate constant (λz)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Mean residence time in the body from 0 to the time t of the last quantifiable drug concentration (MRT0-t)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Mean Residence time from 0 to infinite (MRT0-Inf)
Measured: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Incidence of anti-drug antibody (ADA)
Number of positive participants with ADA positive.
Measured: Once before each of the first five doses and once every 3 months thereafter, and 30 Days after the last dose.
Objective response rate (ORR) (in stage Ⅰ)
Percentage of participants with CR or PR.
Measured: Approximately 2 years in stage Ⅰ
Disease control rate (DCR)(in stage Ⅰ)
Percentage of participants with CR or PR or SD.
Measured: Approximately 2 years in stage Ⅰ
Duration of response (DOR)(in stage Ⅰ)
DOR is defined as the time from first objective response (CR or PR per RECIST v 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v 1.1) or death from any cause, whichever occurs first.
Measured: Approximately 2 years in stage Ⅰ
Progression-free survival (PFS) (in stage Ⅰ)
PFS is defined as the time from first dose to the first observation of disease progression (based on central reading) or death from any cause (as assessed by the independent reviewer).
Measured: Approximately 2 years in stage Ⅰ
Overall survival (OS) (in stage Ⅰ)
OS is defined as the time from first dose to death from any cause.
Measured: Approximately 2 years in stage Ⅰ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study startApr 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaRock Biotherapeutics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153096
- Sponsor's protocol ID
- NBL-015-CSP-001
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of NBL-015 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05153096
- Acronym / sponsor ID
- NBL-015-CSP-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- NovaRock Biotherapeutics, LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2021 (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 trial is an open-label, multicenter, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of NBL-015 in patients with advanced solid tumors.
Detailed description
This study is a multicenter, open-label phase I clinical trial conducted in patients with CLDN18.2-positive advanced solid tumors, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of NBL-015 in patient with advanced solid tumors.
This study consists of two stages: the stage I (dose escalation and dose expansion) and the stage II (NBL-015 monotherapy cohort expansion and combination of NBL-015 with standard treatment cohort expansion).
The dose escalation phase is divided into 5 dose levels. NBL-015 is escalated in order of 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg until MTD. If MTD is still not observed in the preset highest dose group, the investigator and the sponsor can jointly decide whether to conduct a higher dose group study. If necessary, intermediate doses may be conducted. The first dose group (1 mg/kg) is the accelerated titration group, in which 1 patient will be enrolled, and the "3+3" dose escalation design will be followed from the second dose group.
If RP2D can be determined based on clinical study data in the dose escalation stage, Stage II cohort expansion will be directly conducted. Alternatively, based on the safety, tolerability and efficacy data obtained from dose-escalation studies, dose expansion and different dosing can be explored if necessary.
Based on available PK and clinical efficacy data, appropriate dose groups will be selected for cohort expansion. The cohort expansion stage includes the NBL-015 monotherapy cohort expansion trial and the combination of NBL-015with standard treatment cohort expansion trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: solid tumors | Experimental | Drug: NBL-015Dose-escalation stage: Patients will receive NBL-015 once every two or three weeks, starting at a dose of 1 mg/kg. Cohort-expansion stage: Patients will receive NBL-015 at selected dose as per the results of dose-escalation stage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18, ≤75 years, (subject to the date of signing the informed consent) who voluntarily sign the informed consent.
- Positive expression of Claudin 18.2 which is defined as moderate to severe membrane staining (2+/3+) in ≥50% of tumor cells tested by central laboratory immunohistochemistry (IHC).
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors.
- At least one measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Key exclusion criteria (17 listed)
- A history of other malignancies within 3 years prior to first dose, except for locally curable cancers.
- Patients with central nervous system metastases.
- Gastrointestinal abnormalities include:
- Patient with a history of serious cardiovascular disease.
- A history of severe autoimmune disease that the investigator judged inappropriate for inclusion.
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-015NBL-015 by intravenous infusion | Drug | Experimental: solid tumors |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Approximately 4 years
Incidence of adverse events (AEs) of single and multiple dose (according to NCI CTCAE 5.0).An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Incidence of serious adverse events (SAEs)
Time frame: Approximately 4 years
Incidence of serious adverse events (SAEs) of single and multiple dose (according to NCI CTCAE 5.0).
Maximum tolerated dose (MTD) (if available)
Time frame: Approximately 1 year
MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities.
Dose Limiting Toxicity (DLT )
Time frame: Up to 28 days after first injection
Dose-limiting toxicity in patients with advanced tumors treated by NBL-015.
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 2 years
RP2D will be determined using available safety and efficacy data.
Objective response rate (ORR) (in stage Ⅱ)
Time frame: Approximately 2 years in stage Ⅱ
Percentage of participants with CR or PR.
Disease control rate (DCR) (in stage Ⅱ)
Time frame: Approximately 2 years in stage Ⅱ
Percentage of participants with CR or PR or SD.
Duration of response (DOR) (in stage Ⅱ)
Time frame: Approximately 2 years in stage Ⅱ
DOR is defined as the time from first objective response (CR or PR per RECIST v 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v 1.1) or death from any cause, whichever occurs first.
Progression-free survival (PFS) (in stage Ⅱ)
Time frame: Approximately 2 years in stage Ⅱ
PFS is defined as the time from first dose to the first observation of disease progression (based on central reading) or death from any cause (as assessed by the independent reviewer).
Overall survival (OS) (in stage Ⅱ)
Time frame: Approximately 2 years in stage Ⅱ
OS is defined as the time from first dose to death from any cause.
17 secondary outcomes
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Pharmacokinetic (PK)
Time frame: Up to 21 Days after the sixth injection in stage I, after the fifth injection in stage II.
Incidence of anti-drug antibody (ADA)
Time frame: Once before each of the first five doses and once every 3 months thereafter, and 30 Days after the last dose.
Objective response rate (ORR) (in stage Ⅰ)
Time frame: Approximately 2 years in stage Ⅰ
Disease control rate (DCR)(in stage Ⅰ)
Time frame: Approximately 2 years in stage Ⅰ
Duration of response (DOR)(in stage Ⅰ)
Time frame: Approximately 2 years in stage Ⅰ
Progression-free survival (PFS) (in stage Ⅰ)
Time frame: Approximately 2 years in stage Ⅰ
Overall survival (OS) (in stage Ⅰ)
Time frame: Approximately 2 years in stage Ⅰ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Zhongshan Hospital affiliated to Fudan University
Shanghai, 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-015 in people with Advanced Solid 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 8 inclusion and 17 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 3 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Approximately 4 years). The study lists 10 primary outcomes in all. 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 3 Jan 2022.