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NB003 for Solid Cancer
Phase 1
Recruiting
Research Sponsored by Ningbo Newbay Technology Development Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For dose escalation phase: 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 PDGFRα gene alterations (central laboratory confirmation is not required for screening). For dose expansion phase: Cohort 1: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to at least imatinib, sunitinib, regorafenib and ripretinib (≥ fifth line therapy setting); Cohort 2a: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and sunitinib, and who have not received additional systemic therapy for advanced GIST (third line therapy setting); Cohort 2b: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib, sunitinib and regorafenib, and who have not received additional systemic therapy for advanced GIST (forth line therapy setting); Cohort 3: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and have not received additional systemic therapy for advanced GIST (second line therapy setting); Cohort 4: GIST patients with PDGFRα exon 18 mutation and must have progressed on or been intolerant to avapritinib; in the countries/regions where avapritinib is not SoC, avapritinib-naïve patients can be enrolled; Cohort 5: Unresectable or metastatic melanoma patients with demonstrated evidence for KIT gene mutation and/or amplification, must have progressed on or been intolerant to SoCs; Cohort 6: Patients with other advanced malignancies other than GIST or melanoma which must be relapsed or refractory without an available effective therapy and harbor KIT or PDGFRα gene alterations. For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST
Tumor sample collection is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled
Awards & highlights
Study Summary
This trial is testing a new drug, NB003, to see if it is safe and tolerated by people with advanced solid tumors.
Who is the study for?
Adults over 18 with advanced solid tumors, particularly GIST or those with KIT/PDGFRα gene alterations who've exhausted standard treatments. They should have a life expectancy of at least 12 weeks, good performance status (able to carry out daily activities), and proper organ/marrow function. Can't join if they've had recent cancer therapy, major surgery, CNS metastases, active infections like hepatitis/HIV, severe diseases that could affect the trial's safety or results.Check my eligibility
What is being tested?
The study is testing NB003 tablets on patients with advanced malignancies to evaluate their safety and how the body processes them. It's an early-phase trial (Phase 1) where everyone gets NB003; there are no comparison groups. The trial has two parts: dose escalation to find the right dose and expansion to test it further in specific patient groups.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily assessing safety and tolerability, detailed side effects of NB003 aren't listed yet. Generally, such trials look for any adverse reactions ranging from mild symptoms like nausea to more serious ones affecting organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a sample of my tumor for testing.
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My cancer is advanced and cannot be removed by surgery.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Incidence of dose-limiting toxicities
Secondary outcome measures
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Duration of Response(DOR)
Maximum observed plasma concentration (Cmax)
+3 moreOther outcome measures
Cancer relevant gene mutations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation Phase and Dose Expansion PhaseExperimental Treatment1 Intervention
Dose escalation cohort:
NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
RP2D: one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s)
Dose expansion phase:
In the dose expansion phase, additional patients will be enrolled at RP2D to further explore the safety, tolerability, PK, efficacy and biological activity of NB003 in specific disease cohorts, including GIST and other malignancies harboring genomic alterations of KIT or PDGFRα.
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Who is running the clinical trial?
Ningbo Newbay Technology Development Co., LtdLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received targeted radiation for symptom relief within the last week.I have not had major surgery in the last 4 weeks.I am 18 years old or older.I haven't had cancer treatment in the last 2-3 weeks.I have provided a sample of my tumor for testing.I am not taking any strong CYP3A4 inhibitors or inducers.I do not have active brain metastases, meningitis, hepatitis B, hepatitis C, or HIV.My organs and bone marrow are working well.My cancer is advanced and cannot be removed by surgery.I am fully active or can carry out light work.I am using acid-reducing medication and cannot stop it 2 weeks before starting the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Phase and Dose Expansion Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the population sample participating in this research endeavor?
"That is correct. Clinicaltrials.gov reveals that this clinical trial opened for enrollment on August 6th 2021 and was last edited on January 29th 2022. The research team is looking to recruit 36 patients from a single site."
Answered by AI
Are there any attendant risks when using NB003 tablets?
"Due to a lack of supporting evidence, our team at Power assigned NB003 tablets a score of 1 on the safety scale. This is due to it being part of Phase 1 trials which have limited clinical data confirming its efficacy and safety."
Answered by AI
What results are researchers expecting to see from this clinical experiment?
"This trial, which will take up to 2 years for the first subject enrolled, aims to observe any adverse effects. Other objectives include monitoring duration of response (DOR), objective response rate (ORR) and area under the curve (AUC)."
Answered by AI
Are there still vacancies available to participate in this research project?
"That is correct. On clinicaltrials.gov, it states that this study, which was published on the 6th of August 2021, is still seeking participants. A total of 36 patients are to be enrolled across a single research centre."
Answered by AI
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