A Study of NB003 in Patients With Advanced Malignancies

Completed · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB003 in Subjects with Advanced Malignancies

Key facts

Study ID: NCT04936178
Run by: Ningbo Newbay Technology Development Co., Ltd
People needed: 258
Starts: 2021-08-06
Expected to finish: 2025-08-01
Last updated by the study team: 2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males or females of any race ≥18 years age.
Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or other advanced malignancies.
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.
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.

You may not qualify if…

Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum wash-out period of 21 days prior to the initiation of study drug administration.
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.
Any known active central nervous system metastases and/or carcinomatous meningitis. Active infection including hepatitis B, hepatitis C, and HIV.
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.
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.

Where it is running

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

Full record on ClinicalTrials.gov

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