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A Study of NB003 in Patients With Advanced Malignancies

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: NCT04936178
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Ningbo Newbay Technology Development Co., Ltd

Tracking Information
First Submitted Date  ICMJE June 3, 2021
First Posted Date  ICMJE June 23, 2021
Last Update Posted Date February 14, 2022
Actual Study Start Date  ICMJE August 6, 2021
Estimated Primary Completion Date April 24, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
  • Incidence of dose-limiting toxicities [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Dose-limiting toxicities will be reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
  • Incidence of adverse events [ Time Frame: Approximately 24 months since the first subject enrolled ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
  • 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 measurable concentration.
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Maximum observed plasma concentration (Cmax)
  • Time to Cmax (Tmax) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Time to Cmax (Tmax)
  • Terminal elimination half life [ Time Frame: Approximately 24 months since the first subject enrolled ]
    Terminal elimination half life
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of NB003 in Patients With Advanced Malignancies
Official Title  ICMJE A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies
Brief Summary This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB003 in Subjects with Advanced Solid Tumors
Detailed Description

This is a phase 1, open-label, multicenter study of NB003 administered orally in patients with advanced GIST who have progressed on or had an intolerability to imatinib and other standard of care (SoCs) or refused other SoCs, and patients with an advanced malignancy other than Gastrointestinal stromal tumor (GIST)that harbors KIT(CD117) or platelet derived growth factor receptor（PDGFRa) gene alteration who have relapsed or have refractory disease without an available effective therapy.

The study is comprised of a dose escalation phase to determine the MTD and the RP2D and an expansion phase to further explore the safety and efficacy of NB003.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: NB003 tablets
NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
Study Arms  ICMJE Experimental: NB003
Dose escalation cohort: NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
Intervention: Drug: NB003 tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2021)		 36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 6, 2023
Estimated Primary Completion Date April 24, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or females of any race ≥18 years age.
  2. Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or another advanced solid tumor. GIST patients must have progressed on or had an intolerability to imatinib and other SoCs or refused other SoCs. Patients with an advanced solid tumor other than GIST must have relapsed or had refractory disease without an available effective therapy and harbor KIT or PDGFRa gene alteration.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Life expectancy ≥ 12 weeks.
  5. Adequate organ and marrow function.
  6. Tumor sample collection is required.

Exclusion Criteria:

  1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, before the first dose.
  2. Major surgery within 4 weeks of the first dose.
  3. Radiotherapy with a limited field of radiation for palliation within 1 week prior to the first dose, with the exception as defined.
  4. Patients currently receiving medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4.
  5. Patients currently receiving acid-reducing agents and are unable to stop use at least 2 weeks prior to the first dose.
  6. Spinal cord compression or brain metastases.
  7. Active infection including hepatitis B, hepatitis C, and HIV.
  8. Any evidence of severe or uncontrolled systemic diseases which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaoling Xue +8613811929813 TMF-ISF@newbaypharma.com
Contact: Yanhua Xu +8613916714882 TMF-ISF@newbaypharma.com
Listed Location Countries  ICMJE China,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04936178
Other Study ID Numbers  ICMJE NB003-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ningbo Newbay Technology Development Co., Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ningbo Newbay Technology Development Co., Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ningbo Newbay Technology Development Co., Ltd
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP