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Testing NB003 in patients with advanced cancers

A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies

Phase 1 Interventional Ningbo Newbay Technology Development Co., Ltd · NCT04936178

This study is testing a new drug called NB003 in patients with advanced cancers, specifically those with gastrointestinal stromal tumors that haven't responded to other treatments, to see how safe it is and what the best dose might be.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment258 (estimated)
Ages18 Years and up
SexAll
SponsorNingbo Newbay Technology Development Co., Ltd Industry-sponsored
Drugs / interventionsimatinib, sunitinib, ripretinib, avapritinib, radiation
Locations34 sites (Stanford, California and 33 other locations)
Trial IDNCT04936178 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open-label, multicenter study evaluating the safety, tolerability, and pharmacokinetics of NB003 in patients with advanced malignancies. The study includes a dose escalation phase to determine the maximum tolerated dose (MTD) and a dose expansion phase to further assess the drug's safety and efficacy. Patients with advanced gastrointestinal stromal tumors (GIST) who have not responded to standard treatments or have specific gene alterations will be enrolled. The study aims to establish the recommended phase 2 dose (RP2D) for further exploration.

Who should consider this trial

Good fit: Ideal candidates include adults with unresectable, relapsed, or metastatic GIST or other advanced solid tumors with specific gene alterations.

Not a fit: Patients with early-stage cancers or those who have not progressed on standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced malignancies that have limited effective therapies.

How similar studies have performed: Other studies targeting similar genetic alterations in advanced malignancies have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Stanford, California and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumor
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.