A Study of NB004 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-09-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 in Subjects with Advanced Solid Tumors

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ningbo Newbay Technology Development Co., Ltd

Criteria

Inclusion 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.

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.

Exclusion Criteria:

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.