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A Study of NB003 in Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT04936178
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Ningbo Newbay Technology Development Co., Ltd

Brief Summary:
This a 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: NB003 tablets Phase 1

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.

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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 Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies
Actual Study Start Date : August 6, 2021
Estimated Primary Completion Date : April 24, 2023
Estimated Study Completion Date : July 6, 2023

Arm Intervention/treatment
Experimental: NB003
Dose escalation cohort: NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
Drug: NB003 tablets
NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

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

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

  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.



Information from the National Library of Medicine

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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-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.

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): NCT04936178


Contacts
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Contact: Yan Wang +8615388232733 TMF-ISF@newbaypharma.com

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Dasstas Jacqueline    646-888-3915    dastasj@mskcc.org   
Principal Investigator: Chi Ping         
Sponsors and Collaborators
Ningbo Newbay Technology Development Co., Ltd
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Responsible Party: Ningbo Newbay Technology Development Co., Ltd
ClinicalTrials.gov Identifier: NCT04936178    
Other Study ID Numbers: NB003-01
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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