Advanced Solid TumorPhase 1NCT06223256
A Study of NBL-028 in Patients With Advanced Solid Tumors
A Phase 1 study testing NBL-028 in people with Advanced Solid Tumor, run by NovaRock Biotherapeutics, Ltd at 1 site in China.
Trial summary
This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- NBL-028
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2024to Jan 2027
- 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
- Patients ≥18 years old, should have fully understood the study and voluntarily signed an informed consent form.
- Patients with pathologically diagnosed advanced solid tumors with positive expression of CLDN6. Stage I: Patients have failed or cannot tolerate standard of care, or without standard treatment; Stage Ⅱ: Previously treated advanced solid tumors.
- Be able to provide previously well-preserved tumor tissue sections, or agree to undergo tumor tissue biopsy for central laboratory biomarker testing.
- At least one measurable target lesion according to RECIST 1.1.
- ECOG performance status of 0 or 1 at screening.
- Life expectancy ≥3 months.
- Adequate organ function within 7 days prior to the first dose defined as: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥100×10^9/L;. Hemoglobin (HGB) ≥90 g/L; Serum creatinine ≤ 1.5 × ULN or Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥50 mL/min; Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN when patients with Gilbert's disease); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement is known).
- Serum pregnancy test for women of childbearing potential (WOCBP) is negative within 7 days prior to the first dose of the investigational drug. The patient and his/her spouse must agree to use adequate contraception from signing of informed consent form (ICF) to 3 months after the last dose, during which women should be non-lactating and men should refrain from donating sperm.
Who cannot join
- Previously received CLDN6-targeted or CD137-targeted treatment.
- Known uncontrolled central nervous system (CNS) cancer including CNS metastasis, meningeal metastasis, or spinal cord compression.
- Patients with high risk of bleeding due to tumor invasion of important arteries.
- Has uncontrolled serous cavity effusion (such as pleural effusion, abdominal effusion, or pericardial effusion, etc) requiring repeated drainage.
- Has adverse events due to previous anti-tumor treatments that have not yet recovered to ≤Grade 1 according to NCI-CTCAE v5.0;
- Developed immune-related adverse events (irAE) of grade ≥3 (CTCAE 5.0) with prior immunotherapy
Show all 21Show fewer
- Known to exist any other malignant tumor requiring intervention.
- Have received anti-tumor treatments (such as chemotherapy, targeted therapy, biological therapy, etc.) or any other investigational drugs or treatments within 4 weeks or 5 half-lives, whichever is shorter.
- Have received a live viral vaccine within 4 weeks before the first dose of study drug.
- Have received immunosuppressive medications within 2 weeks prior to the first dose of study drug.
- Have active or serious bacterial, fungal, or viral infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose of study drug.
- Have received radiation therapy or other localized palliative treatment within 2 weeks before the first dose of study drug.
- Have undergone major surgery within 4 weeks before the first dose of study drug, or scheduled to have major surgery during the study.
- Have a history of serious cardiovascular disease.
- Have active or history of autoimmune diseases.
- A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
- Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis.
- Hypersensitive to humanized monoclonal antibody products.
- Women during lactation or pregnancy.
- Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration.
- Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.
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
No.896 East Zhongshan Road, Shijiazhuang, Hebei Province, China.
Shijiazhuang, Hebei
Clinical Trials Information Group
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors
This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion.
Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.
- Conditions
- Advanced Solid Tumor
- Being tested
- NBL-028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBL-028Drug
Intravenous infusion (IV), once every two weeks (one treatment cycle is 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| NBL-028 | Experimental | Patients will be treated with NBL-028 at starting dose of 0.01 mg/kg in dose escalation stage. In dose expansion stage, patients will be treated with NBL-028 at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Receives: Drug: NBL-028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Dose-limiting toxicity
Measured: Up to approximately 1 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE) Incidence, nature, and severity of adverse events will be graded according to the NCI CTCAE v5.0
adverse events (AEs) and severe adverse events (SAEs)
Measured: Up to approximately 3 years
Maximum Tolerated Dose（MTD） of NBL-028
Maximum Tolerated Dose
Measured: Up to approximately 1 years
Recommended Phase 2 dose（RP2D）
Recommended Phase 2 dose
Measured: Up to approximately 1 years
Secondary outcomes (9)
Overall response rate (ORR).Determined using RECIST v1.1 criteria.
Objective response rate
Measured: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Cmax.
Observed maximum concentration
Measured: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Area under curve（AUC）.
AUC0-t
Measured: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Tmax.
Time to maximum concentration
Measured: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter t1/2.
Apparent terminal Half-Life
Measured: Up to approximately 3 years
anti-drug antibody（ADA）
anti-drug antibody titer
Measured: Up to approximately 3 years
Disease control rate（DCR）
Disease control rate
Measured: Up to approximately 3 years
Duration of response (DoR)
Duration of response
Measured: Up to approximately 3 years
Progression free survival（PFS）
Progression free survival
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start8 Mar 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaRock Biotherapeutics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Ph.D, Principal investigator, Sun Yat-Sen University (SYSU) Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223256
- Sponsor's protocol ID
- NBL-028-001
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 18 Mar 2024
- Results posted
- 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 18 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, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06223256
- Acronym / sponsor ID
- NBL-028-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- NovaRock Biotherapeutics, LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jan 2024 (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 is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion.
Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBL-028 | Experimental | Drug: NBL-028Patients will be treated with NBL-028 at starting dose of 0.01 mg/kg in dose escalation stage. In dose expansion stage, patients will be treated with NBL-028 at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥18 years old, should have fully understood the study and voluntarily signed an informed consent form.
- Patients with pathologically diagnosed advanced solid tumors with positive expression of CLDN6. Stage I: Patients have failed or cannot tolerate standard of care, or without standard treatment; Stage Ⅱ: Previously treated advanced solid tumors.
- Be able to provide previously well-preserved tumor tissue sections, or agree to undergo tumor tissue biopsy for central laboratory biomarker testing.
- At least one measurable target lesion according to RECIST 1.1.
- ECOG performance status of 0 or 1 at screening.
Key exclusion criteria (21 listed)
- Previously received CLDN6-targeted or CD137-targeted treatment.
- Known uncontrolled central nervous system (CNS) cancer including CNS metastasis, meningeal metastasis, or spinal cord compression.
- Patients with high risk of bleeding due to tumor invasion of important arteries.
- Has uncontrolled serous cavity effusion (such as pleural effusion, abdominal effusion, or pericardial effusion, etc) requiring repeated drainage.
- Has adverse events due to previous anti-tumor treatments that have not yet recovered to ≤Grade 1 according to NCI-CTCAE v5.0;
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-028Intravenous infusion (IV), once every two weeks (one treatment cycle is 4 weeks). | Drug | NBL-028 |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: Up to approximately 1 years
Dose-limiting toxicity
Incidence and severity of adverse events (AE) and serious adverse events (SAE) Incidence, nature, and severity of adverse events will be graded according to the NCI CTCAE v5.0
Time frame: Up to approximately 3 years
adverse events (AEs) and severe adverse events (SAEs)
Maximum Tolerated Dose（MTD） of NBL-028
Time frame: Up to approximately 1 years
Maximum Tolerated Dose
Recommended Phase 2 dose（RP2D）
Time frame: Up to approximately 1 years
Recommended Phase 2 dose
9 secondary outcomes
Overall response rate (ORR).Determined using RECIST v1.1 criteria.
Time frame: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Cmax.
Time frame: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Area under curve（AUC）.
Time frame: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter Tmax.
Time frame: Up to approximately 3 years
Pharmacokinetic (PK) profile of YBL-006.Assessed by parameter t1/2.
Time frame: Up to approximately 3 years
anti-drug antibody（ADA）
Time frame: Up to approximately 3 years
Disease control rate（DCR）
Time frame: Up to approximately 3 years
Duration of response (DoR)
Time frame: Up to approximately 3 years
Progression free survival（PFS）
Time frame: Up to approximately 3 years
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 18 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Ruihua Xu, Ph.D principal investigator
Sun Yat-Sen University (SYSU) Cancer Center
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-028 in people with Advanced Solid Tumor, 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 21 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 18 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity（DLT） (time frame: Up to approximately 1 years). The study lists 4 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 18 Mar 2024.