A Study of NB003 in Patients With Advanced Malignancies
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose-limiting toxicities [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 [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
- Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) [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) [Approximately 24 months since the first subject enrolled]
Maximum observed plasma concentration (Cmax)
- Time to Cmax (Tmax) [Approximately 24 months since the first subject enrolled]
Time to Cmax (Tmax)
- Terminal elimination half life [Approximately 24 months since the first subject enrolled]
Terminal elimination half life
- Objective Response Rate (ORR) [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) [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
Criteria
Inclusion Criteria:
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Males or females of any race ≥18 years age.
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Life expectancy ≥ 12 weeks.
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Adequate organ and marrow function.
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Tumor sample collection is required.
Exclusion Criteria:
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Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, before the first dose.
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Major surgery within 4 weeks of the first dose.
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Radiotherapy with a limited field of radiation for palliation within 1 week prior to the first dose, with the exception as defined.
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Patients currently receiving medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4.
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Patients currently receiving acid-reducing agents and are unable to stop use at least 2 weeks prior to the first dose.
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Spinal cord compression or brain metastases.
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Active infection including hepatitis B, hepatitis C, and HIV.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 2 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
| 3 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200030 |
Sponsors and Collaborators
- Ningbo Newbay Technology Development Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NB003-01