A Dose Escalation and Expansion Study of NB002 in Participants With Advanced or Metastatic Solid Tumors

NCT05924906 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NB002-101
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  21 days

Secondary Outcomes (9)

• Pharmacokinetics of NB002: Maximum plasma concentration of the study drug (Cmax)

  Up to 12 months

• Pharmacokinetics of NB002: Time to maximum concentration (Tmax)

  Up to 12 months

• Pharmacokinetics of NB002: Minimum plasma concentration of the study drug (Cmin)

  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)

  Up to 12 months

• Objective response (OR)

  Up to 12 months

Study Arms (6)

NB002 dose level 1

EXPERIMENTAL

NB002 is a recombinant humanized IgG1 monoclonal antibody

Drug: NB002

NB002 dose level 2

EXPERIMENTAL

NB002 is a recombinant humanized IgG1 monoclonal antibody

Drug: NB002

NB002 dose level 3

EXPERIMENTAL

NB002 is a recombinant humanized IgG1 monoclonal antibody

Drug: NB002

NB002 dose level 4

EXPERIMENTAL

NB002 is a recombinant humanized IgG1 monoclonal antibody

Drug: NB002

NB002 dose level 5

EXPERIMENTAL

NB002 is a recombinant humanized IgG1 monoclonal antibody

Drug: NB002

NB002 dose level 6

EXPERIMENTAL

NB002 is a recombinant humanized IgG1 monoclonal antibody

Drug: NB002

Interventions

NB002 DRUG

Strength: 100 mg:5 mL solution in a single-use vial Administration: intravenous infusion

NB002 dose level 1; NB002 dose level 2; NB002 dose level 3; NB002 dose level 4; NB002 dose level 5; NB002 dose level 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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:

Sponsors & Collaborators

• Suzhou Neologics Bioscience Co., Ltd.: lead

Central Study Contacts

Alex Cheng

CONTACT

+86 135 2165 0955; alex.cheng@neologicsbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: BOIN design dose escalation scheme for phase Ia

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 29, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share