A Study of NB003 in Patients With Advanced Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04936178|
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : August 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: NB003 tablets||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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)
- 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): NCT04936178
|Contact: Yan Wang||+8615388232733||TMF-ISF@newbaypharma.com|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Dasstas Jacqueline 646-888-3915 email@example.com|
|Principal Investigator: Chi Ping|