Clinical Trials /

A Study of NB003 in Patients With Advanced Malignancies

NCT04936178

Description:

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

Related Conditions:
  • Gastrointestinal Stromal Tumor
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04936178

Trial Eligibility

Document

Title

  • Brief Title: A Study of NB003 in Patients With Advanced Malignancies
  • Official Title: A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies

Clinical Trial IDs

  • ORG STUDY ID: NB003-01
  • NCT ID: NCT04936178

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
NB003 tabletsNB003

Purpose

This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 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.

Trial Arms

NameTypeDescriptionInterventions
NB003ExperimentalDose escalation cohort: NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
  • NB003 tablets

Eligibility 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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Measure:Maximum observed plasma concentration (Cmax)
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description:Maximum observed plasma concentration (Cmax)
Measure:Time to Cmax (Tmax)
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description:Time to Cmax (Tmax)
Measure:Terminal elimination half life
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description:Terminal elimination half life
Measure:Objective Response Rate (ORR)
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description:Objective Response Rate (ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR)
Measure:Duration of Response(DOR)
Time Frame:Approximately 24 months since the first subject enrolled
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ningbo Newbay Technology Development Co., Ltd

Last Updated

August 10, 2021