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New drug NB003 tested in 258 patients with advanced cancers

NCT ID NCT04936178

Disease control Sponsor: Ningbo Newbay Technology Development Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a new drug called NB003 in 258 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check the drug's safety, find the right dose, and see if it could shrink tumors. The study is now complete, and results will help decide if further testing is warranted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

258 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females of any race ≥18 years age. 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: 1. 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. 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.

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Conditions

The condition(s) this trial relates to.

gastrointestinal stromal tumor melanoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Centre Léon Bérard

    Lyon, Rhone, 69373, France

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201315, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350015, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Madrid, 28040, Spain

  • Institut Gustave Roussy

    Villejuif, Val de Marne, 94805, France

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering Cancer Center

    Long Island City, New York, 11101, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100144, China

  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

    Shanghai, Shanghai Municipality, 201315, China

  • Royal Marsden Hospital-London

    London, London, SW36JJ, United Kingdom

  • Samsung Medical Center

    Seoul, Seoul, 05505, South Korea

  • Standford University

    Stanford, California, 32224, United States

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guandong, 510000, China

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guandong, 510080, China

  • The First Affiliated Hospital of Zhejiang University school of medicine

    Hangzhou, Zhejiang, 310003, China

  • The Second Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shaanxi, 710004, China

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 453000, China

  • U T MD Anderson Cancer Center Investigational Pharmacy Services

    Houston, Texas, 77030, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital, Central South University

    Changsha, Huanan, 410008, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.