Testing NB004 for 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

This study is testing a new treatment called NB004 to see if it is safe and effective for people with advanced solid tumors that have no other treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ningbo Newbay Technology Development Co., Ltd (Industry-sponsored)
• Locations: 4 sites (New Orleans, Louisiana and 3 other locations)
• Trial ID: NCT05036291 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, multicenter study evaluates the safety, tolerability, and pharmacokinetics of NB004, administered either alone or in combination, in patients with advanced solid tumors that have no standard treatment options left. The study includes a dose escalation phase to identify the maximum tolerated dose and a subsequent expansion phase to further assess safety and preliminary antitumor activity. Participants must have a confirmed diagnosis of advanced solid tumors and meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that are metastatic and have a confirmed KRAS G12C mutation.

Not a fit: Patients with brain metastases, spinal cord compression, or those who have not recovered from toxicities of previous anti-cancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting advanced solid tumors have shown promise in the past.

Eligibility 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.

Where this trial is running

New Orleans, Louisiana and 3 other locations

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

Study contacts

• Study coordinator: Yunfei Xia

Conditions Advanced Solid Tumor