Advanced Solid TumorPhase 1NCT05924906
A Dose Escalation and Expansion Study of NB002 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study testing NB002 in people with Advanced Solid Tumor, run by Suzhou Neologics Bioscience Co., Ltd..
Trial summary
This study is a first-in-human, multicenter, open label, uncontrolled, non-randomized, phase 1a/1b study, to evaluate the safety, tolerability, and preliminary antitumor activity of NB002 in subjects with advanced solid tumors. 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?
- NB002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age at the time of signing informed consent.
- Diagnosis of histological or cytological confirmed locally advanced, recurrent and/or metastatic solid tumors that failed to respond to standard therapy, intolerant/refractory to currently available local therapies, or for whom no appropriate therapies are available (based on the judgement of the Investigator).
- Measurable or non-measurable disease according to RECIST 1.1 in dose escalation stage and at least one measurable lesion is necessary for dose expansion stage.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, and anticipated life expectancy of ≥ 3 months.
- Adequate hematologic function based on the following (with no blood transfusion or hematopoietic stimulating factor therapy within 14 days prior to study drug administration):
- ANC≥1.2 ×10^9/L
Show all 21Show fewer
- Platelet count ≥75×10^9/L
- Hemoglobin ≥8.0 g/dL
- Adequate coagulation parameters based on the following:
- Prothrombin Time-International Normalized Ratio (PT-INR) ≤1.5×ULN (upper limit of normal), unless coumarin derivatives are used.
- Activated partial thromboplastin time (aPTT) ≤1.5×ULN. Subjects on anticoagulants may have coagulation parameters that exceed the criteria defined above.
- Adequate hepatic function based on the following:
- Total bilirubin (TBIL) ≤1.5 × ULN and/or isolated elevations of indirect bilirubin are eligible for study participation.
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN for subjects with known hepatic metastases).
- Adequate renal function based on serum creatinine clearance ≥30 mL/min (normal to moderate renal impairment) as determined by Cockcroft-Gault equation.
- A female patient is eligible to participate if she is not pregnant or breastfeeding, and
- is not a WOCBP or
- A WOCBP must have a negative pregnancy test within 72 hours before the first dose of study drug administration, and additional pregnancy testing during and after study drug as defined in the SOA .
- A WOCBP must consent to use highly effective contraceptive methods or abstain from heterosexual activity from screening through 120 days following the last dose of study treatment.
- Fertile male subjects, defined as all males physiologically capable of conceiving offspring, with their WOCBP partner(s) must agree to use highly effective contraception. Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to abstain from sexual intercourse or use barrier contraception from Screening through 120 days following the last dose of study treatment.
- Ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
Who cannot join
- Inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first administration of study drug.
- Has had a known or suspected hypersensitivity reaction to treatment with a mAb and/or the excipients of NB002.
- Prior treatment with other TIM-3 inhibitors (e.g., mAbs).
- Prior palliative radiotherapy within 1 week of start of study treatment. Subjects must have recovered (CTCAE Grade ≤1) from all radiation-related toxicities.
- Any antitumor agent for the primary malignancy without delayed toxicity within 4 weeks or 5 half-lives, whichever is shorter, prior to first administration of study drug, except for Nitrosoureas and mitomycin C within 6 weeks prior to first administration of study drug and during study.
- Active CNS metastases, however, subjects who have undergone definitive radiation and/or surgery for the treatment of CNS metastases, who are stable by radiographic and clinical (neurological) assessment (performed within 4 weeks prior to first trial drug administration), and who are no longer taking pharmacologic doses of corticosteroids are eligible; subjects with leptomeningeal metastases or primary CNS malignancies (such as glioma, glioblastoma) are not eligible.
Show all 20Show fewer
- Evidence of metastatic ileus on computed tomography (CT) scan.
- Patients with concurrent hematologic malignancies.
- Known active or prior infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first administration of study drug.
- Patients with an active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications. procedure is allowed if all other inclusion/exclusion criteria are met.
- History of organ transplantation (e.g., stem cell or solid organ transplant)
- A significant pulmonary disease or condition.
- Patients with a current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
- History of immune-related toxicity during prior treatment with an immune checkpoint inhibitor (ICI, e.g., PD-1/PD-L1 or CTLA-4 inhibitor), including any grade ≥3, and neurologic and/or ocular immune-related toxicity, pneumonitis, or cardiomyopathy of any grade that necessitated permanent discontinuation of that therapy. Patients with other Grade 1-2 immune-related toxicities on prior ICI therapy that have resolved are NOT excluded. Endocrine immune-related toxicities of grade <3 are allowed, as long as they are controlled and/or asymptomatic. Substitution therapy following an immune-related endocrinopathy is allowed.
- Unresolved > Grade 1 toxicity associated with any prior antitumor therapy except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, lymphopenia, hypomagnesemia, and/or end-organ failure being adequately managed by hormone replacement therapy:
- Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable. Active uncontrolled bleeding or a known bleeding diathesis.
- Vaccination with live vaccine(s) within 1 month prior to administration.
- Baseline QT interval corrected with Fridericia's method (QTcF) >470 ms (average of triplicate electrocardiograms [ECG]).
- Unstable or severe uncontrolled medical condition (e.g., uncontrolled diabetes), psychiatric illness/social situations, or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 1a/1b, First-in-Human, Open Label, Dose Escalation and Dose Expansion Study of NB002, a Multifunctional TIM-3 Blocking Antibody, in Subjects With Advanced or Metastatic Solid Tumors
This study is a first-in-human, multicenter, open label, uncontrolled, non-randomized, phase 1a/1b study, to evaluate the safety, tolerability, and preliminary antitumor activity of NB002 in subjects with advanced solid tumors.
Read the detailed description
This study is a first-in-human, multicenter, open-label, uncontrolled, non-randomized, phase 1a/1b study. The study consists of a dose escalation part and a dose expansion part. In the escalation part, the primary objectives are to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) to establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or maximum administered dose (MAD) of NB002. The expansion part is to further evaluate the safety and tolerability of NB002 at the RDE dose established in the dose escalation part and to explore antitumor activity in the selected population. All subjects will be treated with NB002 via IV infusion at predefined dose levels Q3W on Day 1 of each 21-day Cycle.
The design of the dose escalation part will be provided below. Further details on dose expansion part will be updated later once more information on potentially benefiting tumor types is confirmed.
- Conditions
- Advanced Solid Tumor
- Being tested
- NB002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB002Drug
Strength: 100 mg:5 mL solution in a single-use vial Administration: intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| NB002 dose level 1 | Experimental | NB002 is a recombinant humanized IgG1 monoclonal antibody Receives: Drug: NB002 |
| NB002 dose level 2 | Experimental | NB002 is a recombinant humanized IgG1 monoclonal antibody Receives: Drug: NB002 |
| NB002 dose level 3 | Experimental | NB002 is a recombinant humanized IgG1 monoclonal antibody Receives: Drug: NB002 |
| NB002 dose level 4 | Experimental | NB002 is a recombinant humanized IgG1 monoclonal antibody Receives: Drug: NB002 |
| NB002 dose level 5 | Experimental | NB002 is a recombinant humanized IgG1 monoclonal antibody Receives: Drug: NB002 |
| NB002 dose level 6 | Experimental | NB002 is a recombinant humanized IgG1 monoclonal antibody Receives: Drug: NB002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AE), serious adverse events (SAE)
AEs will be evaluated by the investigator, according to criteria outlined in the NCI CTCAE version 5.0
Measured: Up to 12 months
Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
All toxicities will be graded according to NCI CTCAE version 5.0 based on the investigator assessment. The DLT window of observation will be during Cycle 1 (21 days).
Measured: 21 days
Secondary outcomes (9)
Pharmacokinetics of NB002: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma or serum concentration.
Measured: Up to 12 months
Pharmacokinetics of NB002: Time to maximum concentration (Tmax)
Time to maximum concentration.
Measured: Up to 12 months
Pharmacokinetics of NB002: Minimum plasma concentration of the study drug (Cmin)
Minimum observed plasma or serum concentration over the dose interval.
Measured: Up to 12 months
Pharmacokinetics of NB002: Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-t)
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measured: Up to 12 months
Objective response (OR)
Complete response (CR) or partial response (PR), as defined by RECIST v1.1
Measured: Up to 12 months
Progression free survival (PFS)
The time from first dose of study intervention until the date of objective disease progression or death
Measured: Up to 12 months
Duration of response (DOR)
The time from first response according to RECIST v1.1 until progression or death
Measured: Up to 12 months
Pharmacodynamics (PD) activity (Level of binding of NB002 to TIM-3 )
Receptor occupancy in peripheral blood mononuclear cells (PBMCs) or whole fresh blood
Measured: Up to approximately 3 months
Immunogenicity of NB002
The number and percentage of participants who develop detectable anti-drug antibodies (ADA).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study startOct 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (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
- Non-randomised
- Intervention model
- Sequential
- Model description
- BOIN design dose escalation scheme for phase Ia
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Neologics Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924906
- Sponsor's protocol ID
- NB002-101
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1a/1b, First-in-Human, Open Label, Dose Escalation and Dose Expansion Study of NB002, a Multifunctional TIM-3 Blocking Antibody, in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05924906
- Acronym / sponsor ID
- NB002-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suzhou Neologics Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Jun 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 is a first-in-human, multicenter, open label, uncontrolled, non-randomized, phase 1a/1b study, to evaluate the safety, tolerability, and preliminary antitumor activity of NB002 in subjects with advanced solid tumors.
Detailed description
This study is a first-in-human, multicenter, open-label, uncontrolled, non-randomized, phase 1a/1b study. The study consists of a dose escalation part and a dose expansion part. In the escalation part, the primary objectives are to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) to establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or maximum administered dose (MAD) of NB002. The expansion part is to further evaluate the safety and tolerability of NB002 at the RDE dose established in the dose escalation part and to explore antitumor activity in the selected population. All subjects will be treated with NB002 via IV infusion at predefined dose levels Q3W on Day 1 of each 21-day Cycle.
The design of the dose escalation part will be provided below. Further details on dose expansion part will be updated later once more information on potentially benefiting tumor types is confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- BOIN design dose escalation scheme for phase Ia
| Arm | Type | Receives |
|---|---|---|
| NB002 dose level 1 | Experimental | Drug: NB002NB002 is a recombinant humanized IgG1 monoclonal antibody |
| NB002 dose level 2 | Experimental | Drug: NB002NB002 is a recombinant humanized IgG1 monoclonal antibody |
| NB002 dose level 3 | Experimental | Drug: NB002NB002 is a recombinant humanized IgG1 monoclonal antibody |
| NB002 dose level 4 | Experimental | Drug: NB002NB002 is a recombinant humanized IgG1 monoclonal antibody |
| NB002 dose level 5 | Experimental | Drug: NB002NB002 is a recombinant humanized IgG1 monoclonal antibody |
| NB002 dose level 6 | Experimental | Drug: NB002NB002 is a recombinant humanized IgG1 monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female ≥18 years of age at the time of signing informed consent.
- Diagnosis of histological or cytological confirmed locally advanced, recurrent and/or metastatic solid tumors that failed to respond to standard therapy, intolerant/refractory to currently available local therapies, or for whom no appropriate therapies are available (based on the judgement of the Investigator).
- Measurable or non-measurable disease according to RECIST 1.1 in dose escalation stage and at least one measurable lesion is necessary for dose expansion stage.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, and anticipated life expectancy of ≥ 3 months.
- Adequate hematologic function based on the following (with no blood transfusion or hematopoietic stimulating factor therapy within 14 days prior to study drug administration):
Key exclusion criteria (20 listed)
- Inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first administration of study drug.
- Has had a known or suspected hypersensitivity reaction to treatment with a mAb and/or the excipients of NB002.
- Prior treatment with other TIM-3 inhibitors (e.g., mAbs).
- Prior palliative radiotherapy within 1 week of start of study treatment. Subjects must have recovered (CTCAE Grade ≤1) from all radiation-related toxicities.
- Any antitumor agent for the primary malignancy without delayed toxicity within 4 weeks or 5 half-lives, whichever is shorter, prior to first administration of study drug, except for Nitrosoureas and mitomycin C within 6 weeks prior to first administration of study drug and during study.
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 |
|---|---|---|
| NB002Strength: 100 mg:5 mL solution in a single-use vial Administration: intravenous infusion | Drug | NB002 dose level 1, NB002 dose level 2, NB002 dose level 3, NB002 dose level 4, NB002 dose level 5, NB002 dose level 6 |
Primary outcome
Number of participants with adverse events (AE), serious adverse events (SAE)
Time frame: Up to 12 months
AEs will be evaluated by the investigator, according to criteria outlined in the NCI CTCAE version 5.0
Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
Time frame: 21 days
All toxicities will be graded according to NCI CTCAE version 5.0 based on the investigator assessment. The DLT window of observation will be during Cycle 1 (21 days).
9 secondary outcomes
Pharmacokinetics of NB002: Maximum plasma concentration of the study drug (Cmax)
Time frame: Up to 12 months
Pharmacokinetics of NB002: Time to maximum concentration (Tmax)
Time frame: Up to 12 months
Pharmacokinetics of NB002: Minimum plasma concentration of the study drug (Cmin)
Time frame: Up to 12 months
Pharmacokinetics of NB002: Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-t)
Time frame: Up to 12 months
Objective response (OR)
Time frame: Up to 12 months
Progression free survival (PFS)
Time frame: Up to 12 months
Duration of response (DOR)
Time frame: Up to 12 months
Pharmacodynamics (PD) activity (Level of binding of NB002 to TIM-3 )
Time frame: Up to approximately 3 months
Immunogenicity of NB002
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NB002 in people with Advanced Solid Tumor, run by Suzhou Neologics Bioscience Co., Ltd..
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 21 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 3 Jul 2023. 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. 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?
Contact Alex Cheng (+86 135 2165 0955, alex.cheng@neologicsbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AE), serious adverse events (SAE) (time frame: Up to 12 months). 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?
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 Jul 2023.