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

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

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Portland

Providence Cancer Institute, Portland, Oregon, United States, 97213

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ningbo Newbay Technology Development Co., Ltd,

Study Record Dates

2025-06-01