NB004 for Solid Tumors

Recruiting at 4 trial locations

Overseen By Lanjiao Wu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ningbo Newbay Technology Development Co., Ltd

Must not be taking: PIM kinase inhibitors

Disqualifiers: Brain metastases, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NB004 for individuals with certain advanced solid tumors (cancers in organs or tissues). It aims to assess the safety and tolerability of NB004 both alone and in combination with another drug, Sotorasib. The trial includes different parts to determine the best use of NB004, particularly in tumors with the KRAS G12C mutation. Suitable candidates have advanced solid tumors without standard treatment options or possess a specific genetic mutation. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have had any anti-cancer therapy within 2 weeks or at least 5 half-lives before starting the trial.

Is there any evidence suggesting that NB004 is likely to be safe for humans?

Research has shown that NB004 is still under study to ensure its safety when used alone. The primary goal is to determine the optimal dose that minimizes side effects. As this is an early stage of testing, solid information on its tolerability is not yet available.

When combined with sotorasib, more information is available. Sotorasib has been safely used in other cancer treatments and received approval for treating a type of lung cancer after successful studies. This offers hope for the combination's safety, but further testing is necessary to confirm this.

Overall, since this trial is in an early phase, researchers are focused on understanding the safety and tolerability of these treatments for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NB004 for solid tumors because it promises a novel approach compared to current treatments like chemotherapy or targeted therapies. Unlike existing options, which often attack both cancerous and healthy cells, NB004 is designed to work with Sotorasib to target specific cancer pathways more precisely, potentially reducing side effects. This dual approach aims to enhance the efficacy of treatment by specifically targeting tumor cells, offering hope for more effective and less toxic cancer therapies.

What evidence suggests that NB004 might be an effective treatment for solid tumors?

Research has shown that NB004, which participants in this trial may receive, could help treat advanced solid tumors. Early studies demonstrated its effectiveness in fighting tumors. In this trial, researchers will test NB004 both as a monotherapy and in combination with sotorasib. Some studies found that when used with sotorasib, NB004 led to complete tumor disappearance in certain cases. Sotorasib is already known to be effective for some lung cancers. These findings suggest that NB004, whether used alone or with sotorasib, might be a strong treatment option for solid tumors. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced solid tumors lacking standard treatment options. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, measurable disease, and an expected lifespan of at least 12 weeks. They should not have had cancer therapy within the last 2-3 weeks and must not be pregnant or planning pregnancy.

Inclusion Criteria

My advanced cancer has no standard treatment options.

I am fully active or can carry out light work.

Life expectancy of 12 weeks or more

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I plan to try for a child within 3 months after my last treatment dose.

I still have side effects from past cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation phase to determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) of NB004

Approximately 4 weeks per cycle

Multiple visits for dose escalation and monitoring

Dose Expansion

Expansion phase to further explore the safety and preliminary antitumor activity of NB004

Approximately 24 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 24 months

What Are the Treatments Tested in This Trial?

Interventions

• NB004

Trial Overview The study tests NB004 tablets as a single agent or combined with other therapies in patients with advanced solid tumors. It's an early-phase trial (Phase 1) focusing on safety, how well the body tolerates it, and how the drug behaves inside the body (pharmacokinetics).

How Is the Trial Designed?

Group I: NB004 Experimental Treatment 1 Intervention

Part1: Dose escalation phase of study drug NB004 monotherapy: Part 2: Dose Escalation Phase for the NB004 in combination with Sotorasib: Part 3: COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib:

Who Is Running the Clinical Trial?

Ningbo Newbay Technology Development Co., Ltd

Lead Sponsor

Trials

2

Recruited

380+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05036291

NCT05036291 | A Study of NB004 as Monotherapy or ... This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically confirmed diagnosis ...

2. aacrjournals.org aacrjournals.org/cancerres/article/84/7_Supplement/CT116/742612/Abstract-CT116-Preclinical-antitumor-activity-and

Preclinical antitumor activity and first-in-human phase I study ... Based on the promising preclinical data, NB004 is currently being assessed in an open-label, first-in-human phase I clinical trial as ...

3. trialx.com trialx.com/clinical-trials/listings/272797/a-study-of-nb004-as-monotherapy-or-combination-therapy-in-patients-with-advanced-solid-tumors/?&geo_lat=29.7057858&geo_lng=-95.4588299&radius=10&place=Bellaie&user_country=United%20States

A Study of NB004 as Monotherapy or Combination ... This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=7ce1e43a-7f4a-425d-ab5c-7be39254ff85

NB004 / Ningbo Tai Kang Preclinical antitumor activity and first-in-human phase I study of NB004/GDC-0570, a novel pan-PIM kinase inhibitor, in patients with advanced solid tumors ...

5. researchgate.net researchgate.net/publication/379616260_Abstract_CT116_Preclinical_antitumor_activity_and_first-in-human_phase_I_study_of_NB004GDC-0570_a_novel_pan-PIM_kinase_inhibitor_in_patients_with_advanced_solid_tumors

Abstract CT116: Preclinical antitumor activity and first-in- ... Based on the promising preclinical data, NB004 is currently being assessed in an open-label, first-in-human phase I clinical trial as ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2021-09776

A Study of NB004 As Monotherapy or Combination ... This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090863/

Real-World Efficacy and Safety of Sotorasib in U.S. Veterans ... The KRAS G12C inhibitor sotorasib was approved for treating advanced NSCLC in the second line or later on the basis of the CodeBreaK100 trial.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2405803324002759

KRAS inhibitors: resistance drivers and combinatorial ... In 2018, the first clinical trial, CodeBreaK 100 (NCT03600883), started to study the clinical safety of sotorasib in patients with advanced KRASG12C-mutant ...