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

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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

Key facts

Study ID

NCT05036291

Run by

Ningbo Newbay Technology Development Co., Ltd

People needed

25

Starts

2021-10-01

Expected to finish

2025-10-10

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• males or females of any race>(=)18 years age.
• Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).
• Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2\&3).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy>(=)12 weeks.
• Adequate organ and marrow function.
• Measurable or evaluable disease.

You may not qualify if…

• 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.
• Toxicities from previous anti-cancer therapy that have not recovered as required.
• Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.
• Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):
• Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.
• Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.
• Received prior treatment with a PIM kinase inhibitor.

Where it is running

• LSU-LCMC Health Cancer Center — New Orleans, Louisiana, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• National Cheng Kung University Hospital（NCKUH） — Tainan, Taiwan, China
• National Taiwan University Hospital Yunlin Branch — Yunlin, Taiwan, China

Full record on ClinicalTrials.gov

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