A Study of NB003 in Patients With Advanced Malignancies
NCT ID: NCT04936178
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
258 participants
INTERVENTIONAL
2021-08-06
2025-08-01
Brief Summary
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Detailed Description
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The dose escalation phase will enroll patients with advanced gastrointestinal stromal tumor (GIST) who have progressed on or had an intolerability to imatinib and other standard of cares (SoCs) or refused other SoCs, and patients with advanced malignancies other than GIST that harbors KIT or PDGFRα gene alterations who have relapsed or have refractory disease without an available effective therapy. The number of patients to be enrolled during the dose escalation part will vary depending on the underlining dose-toxicity curve and the number of dose levels tested prior to reaching MTD or MAD. After the MTD or MAD has been determined, based on emerging safety/PK data, one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s) to establish the RP2D for dose expansion phase. This step will be regarded as RP2D confirmation part of dose escalation phase.
In the dose expansion phase, additional patients will be enrolled 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. Dose expansion phase is planned to investigate NB003 at the RP2D determined from dose escalation phase.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation Phase and Dose Expansion Phase
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.
NB003 tablets
NB003 tablets will be administered at assigned doses for escalation phase and RP2D doses for expansion phase orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
Interventions
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NB003 tablets
NB003 tablets will be administered at assigned doses for escalation phase and RP2D doses for expansion phase orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
Eligibility Criteria
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Inclusion Criteria
2. Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or other advanced malignancies.
1. 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).
2. 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.
3. For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy ≥ 12 weeks.
6. Adequate organ and marrow function.
7. Tumor sample collection is required.
Exclusion Criteria
2. Major surgery within 4 weeks of the first dose.
3. Radiotherapy with a limited field of radiation for palliation within 1 week prior to the first dose, with the exception as defined.
4. Patients currently receiving medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4.
5. Patients currently receiving acid-reducing agents and are unable to stop use at least 2 weeks prior to the first dose.
6. Any known active central nervous system metastases and/or carcinomatous meningitis. Active infection including hepatitis B, hepatitis C, and HIV.
7. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, uncontrolled pericardial effusion, uncontrolled pleural effusion, or any other conditions, which in the judgment of Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
8. 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.
18 Years
ALL
No
Sponsors
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Ningbo Newbay Technology Development Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Standford University
Stanford, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
Long Island City, New York, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
U T MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, United States
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guandong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guandong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Xiangya Hospital, Central South University
Changsha, Huanan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The Second Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shaanxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, China
Centre Léon Bérard
Lyon, Rhone, France
Institut Gustave Roussy
Villejuif, Val de Marne, France
Asan Medical Center
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, Spain
Royal Marsden Hospital-London
London, London, United Kingdom
Countries
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Other Identifiers
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NB003-01
Identifier Type: -
Identifier Source: org_study_id