A Study of NB003 in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT04936178|
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : February 14, 2022
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males or females of any race ≥18 years age.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Adequate organ and marrow function.
- Tumor sample collection is required.
- Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, before the first dose.
- Major surgery within 4 weeks of the first dose.
- Radiotherapy with a limited field of radiation for palliation within 1 week prior to the first dose, with the exception as defined.
- Patients currently receiving medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4.
- Patients currently receiving acid-reducing agents and are unable to stop use at least 2 weeks prior to the first dose.
- Spinal cord compression or brain metastases.
- Active infection including hepatitis B, hepatitis C, and HIV.
- 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.
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: Xiaoling Xue||+8613811929813||TMF-ISF@newbaypharma.com|
|Contact: Yanhua Xu||+8613916714882||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|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Lin Shen +86 13911219511 firstname.lastname@example.org|
|Fudan University Shanghai Cancer Center||Not yet recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Jian Zhang +86 21 34610367 email@example.com|
|Responsible Party:||Ningbo Newbay Technology Development Co., Ltd|
|Other Study ID Numbers:||
|First Posted:||June 23, 2021 Key Record Dates|
|Last Update Posted:||February 14, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|