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A Study of NB004 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05036291
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Ningbo Newbay Technology Development Co., Ltd

Study Description
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Brief Summary:
This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 in Subjects with Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: NB004 tablets Phase 1

Detailed Description:

This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are metastatic for which all standard treatment options have been given and are ineffective, or is no longer eligible for additional standard treatment options.

The study is comprised of a dose escalation phase to determine the maximum tolerated dose and the RP2D and an expansion phase to further explore the safety and preliminary antitumor activity of NB004.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 in Subjects With Advanced Solid Tumors
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : May 26, 2023
Estimated Study Completion Date : September 26, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: NB004

NB004 dose escalation cohort:

NB004 tablets will be administered orally once a daily for repeated 28-day cycles until discontinuation criteria are met.

 Drug: NB004 tablets
NB004 tablets will be administered orally once daily for repeated 28-day cycles until discontinuation criteria are met.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence dose-limiting toxicities [ Time Frame: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators. ]
    Dose-limiting toxicities will be reviewed as a subset of adverse events that occurs within the first 28 days of dosing and meet protocol-specified criteria.

  2. incidence of adverse events [ Time Frame: Approximately 24 months since the first subject enrolled ]
    An adverse event is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Maximum observed plasma concentration (Cmax)

  2. Time to Cmax (Tmax) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Time to Cmax (Tmax)

  3. Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last

  4. Terminal elimination half life [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Terminal elimination half life

  5. Objective Response Rate (ORR) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Objective Response Rate (ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR)

  6. Duration of Response(DOR) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. males or females of any race>(=)18 years age.
  2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Life expectancy>(=)12 weeks.
  5. Adequate organ and marrow function.
  6. Measurable or evaluable disease.

Exclusion Criteria:

  1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.
  2. Toxicities from previous anti-cancer therapy that have not recovered as required.
  3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis. 4.Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):

5.Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.

6.Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.

7.Received prior treatment with a PIM kinase inhibitor.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05036291


Contacts
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Contact: Yanhua Xu +8613916714882 TMF-ISF@newbaypharma.com

Locations
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United States, Oregon
Providence Cancer Institute Not yet recruiting
Portland, Oregon, United States, 97213
Contact: Larisa Lundgren, Study Start-up Speacilist    503-215-0610    larisa.lundgren@providence.org   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Katherine Torres    832-750-4997    KTorres4@mdanderson.org   
Principal Investigator: Siqing Fu         
Sponsors and Collaborators
Ningbo Newbay Technology Development Co., Ltd
More Information
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Responsible Party: Ningbo Newbay Technology Development Co., Ltd
ClinicalTrials.gov Identifier: NCT05036291    
Other Study ID Numbers: NB004-01
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms