RECRUITING

A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

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Conditions

Advanced Solid Tumor

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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 is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors

Official Title

A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors

Quick Facts

Study Start:2021-10-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05036291

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 CriteriaExclusion Criteria
  1. 1. males or females of any race\>(=)18 years age.
  2. 2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).
  3. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. 4. Life expectancy\>(=)12 weeks.
  5. 5. Adequate organ and marrow function.
  6. 6. Measurable or evaluable disease.
  1. 1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.
  2. 2. Toxicities from previous anti-cancer therapy that have not recovered as required.
  3. 3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.
  4. 4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):
  5. 5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.
  6. 6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.
  7. 7. Received prior treatment with a PIM kinase inhibitor.

Contacts and Locations

Study Contact

Yanhua Xu
CONTACT
+8613916714882
TMF-ISF@newbaypharma.com

Study Locations (Sites)

Providence Cancer Institute
Portland, Oregon, 97213
United States
The University of Texas MD Anderson Cancer Center
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 Date2021-10-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2021-10-01
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor