COMPLETED

A Study of NB003 in Patients With Advanced Malignancies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-08-06

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04936178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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.

Inclusion Criteria

Exclusion 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:
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.

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.

Contacts and Locations

Study Locations (Sites)

Standford University

Stanford, California, 32224

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

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

U T MD Anderson Cancer Center Investigational Pharmacy Services

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Ningbo Newbay Technology Development Co., Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-06

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2021-08-06

Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor