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NCT05036291 | RECRUITING | Advanced Solid Tumor

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

Ningbo Newbay Technology Development Co., Ltd

Brief Summary:

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

Condition or disease

Advanced Solid Tumor

Intervention/treatment

NB004 tablets

Phase

PHASE1

Detailed Description:

This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are metastatic for which all standard treatment options have been given and are ineffective, or is no longer eligible for additional standard treatment options. The study is comprised of a dose escalation phase to determine the maximum tolerated dose and the RP2D and an expansion phase to further explore the safety and preliminary antitumor activity of NB004.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2021-10-01
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2026-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 (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).
  • 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.
A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

Location Details

NCT05036291

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Louisiana

LSU-LCMC Health Cancer Center

New Orleans, Louisiana, United States, 70112

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

China, Taiwan

National Chenial Chesyal Spossalitaￂ

Tainan, Taiwan, China, 008866

NOT YET RECRUITING

China, Taiwan

National Taiwan University Hospital Yunlin Branch

Y UN Forest, Taiwan, China, 886