A Study of NB004 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05036291|
Recruitment Status : Not yet recruiting
First Posted : September 5, 2021
Last Update Posted : September 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: NB004 tablets||Phase 1|
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 Type :||Interventional|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 in Subjects With Advanced Solid Tumors|
|Estimated Study Start Date :||September 3, 2021|
|Estimated Primary Completion Date :||May 26, 2023|
|Estimated Study Completion Date :||September 26, 2023|
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.
- Incidence dose-limiting toxicities [ Time Frame: 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 [ Time Frame: 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.
- 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)
- 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
- 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.
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): NCT05036291
|Contact: Yanhua Xu||+8613916714882||TMF-ISF@newbaypharma.com|
|United States, Oregon|
|Providence Cancer Institute|
|Portland, Oregon, United States, 97213|
|Contact: Larisa Lundgren, Study Start-up Speacilist 503-215-0610 email@example.com|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Katherine Torres 832-750-4997 KTorres4@mdanderson.org|
|Principal Investigator: Siqing Fu|