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New cancer drug NB004 tested in Early-Stage trial

NCT ID NCT05036291

Disease control Sponsor: Ningbo Newbay Technology Development Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called NB004 in 25 adults with advanced solid tumors that had no standard treatment options. The main goal was to check the drug's safety and how the body processes it. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

  • LSU-LCMC Health Cancer Center

    New Orleans, Louisiana, 70112, United States

  • National Cheng Kung University Hospital（NCKUH）

    Tainan, Taiwan, 008866, China

  • National Taiwan University Hospital Yunlin Branch

    Yunlin, Taiwan, 886, China

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.