A Study of NB004 in Patients With Advanced Solid Tumors
Study Details
Study Description
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 |
|---|---|---|
|
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
Arms and Interventions
| 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
Primary Outcome Measures
- Incidence dose-limiting toxicities [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.
- incidence of adverse events [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
- 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)
- 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
- 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 and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options.
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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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Measurable or evaluable disease.
Exclusion Criteria:
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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.
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Toxicities from previous anti-cancer therapy that have not recovered as required.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Providence Cancer Institute | Portland | Oregon | United States | 97213 |
| 2 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Ningbo Newbay Technology Development Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NB004-01