Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNingbo Newbay Technology Development Co., Ltd
About this trial
NB003-04 is a phase II/III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of NB003 in patients with gastrointestinal stromal tumors aged 18 years and above (or the legal adult age of consent per local regulations, whichever is older). Participants who are eligible for this study are those who have experienced disease progression or documented intolerance following treatment with either imatinib and sunitinib or following treatment with imatinib.
This study consists of two parts. Part 1 (hereinafter referred to as Part 1) compares the efficacy of NB003 versus regorafenib in patients who need a third-line therapy for GIST who have failed sequential therapy with imatinib and sunitinib. Part 2 (hereinafter referred to as Part 2) evaluates the efficacy of NB003 in patients who need a second-line therapy for GIST who have failed treatment with imatinib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants are >=18 years of age (or the legal adult age as per local regulations, whichever is older) at the time of signing the ICF.
Participants, or legally authorized representatives permitted by local regulations, provide written informed consent for participation in the study.
Participants who have histologically confirmed locally advanced, unresectable, or metastatic GIST.
Part 1: Patients who have failed prior treatment with imatinib (including adjuvant therapy) and sunitinib for GIST due to disease progression or intolerance. Participants should also have no prior use of other TKI drugs.
Disqualifiers
Part 1: Participants who have received prior treatment with NB003 or regorafenib. Part 2: Participants who have received prior treatment with NB003 or sunitinib.
Participants who have received any systemic anti-tumor therapy within 7 days prior to enrollment.
Participants who have undergone major surgery (excluding vascular access placement, tumor biopsy, and feeding tube placement) or major palliative interventions (such as transarterial chemoembolization) within 4 weeks prior to enrollment.
Participants who have received radiation therapy to >30% of the bone marrow or extensive radiation therapy within 4 weeks prior to enrollment.
Trial design
Design model
Crossover
Treatments tested in this trial
NB003
Drug15 mg BID on a continuous schedule in 28-day cycles.
regorafenib
DrugRegorafenib is an approved multi-kinase inhibitor administered orally at a dose of 160 mg once daily (QD).
Treatment groups
255 Participants
are divided into 3 treatment groupsGroup A: NB003Experimental treatment 1 intervention
Group B: RegorafenibActive comparator 2 interventions
Group C: NB003（part 2）Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free Survival (PFS)
for part 1
Time frame
From randomization until database cut-off, approximately 28 months2
Objective response rate (ORR)
for part 2
Time frame
approximately 24 months since the first subject enrolledSecondary outcomes
1
Objective response rate (ORR)
for part 1
Time frame
From randomization until database cut-off, approximately 28 months2
Progression-free survival (PFS)
for part 2
Time frame
approximately 24 months since the first subject enrolled3
Duration of Response(DOR)
for part 2
Time frame
approximately 24 months since the first subject enrolled4
Duration of Response(DOR)
for part 1
Time frame
approximately 28 months since the first subject enrolledSponsors and contacts
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Source ClinicalTrials.gov