NP-101 for Liver Cancer

Overseen By Judy Walsh

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Florida

Disqualifiers: Active malignancy, Macrovascular invasion, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called NP-101 for liver cancer that cannot be removed by surgery. Derived from black seed, known for its immune-boosting properties, NP-101 will be evaluated to determine if it can safely assist the immune system in fighting liver cancer alongside standard treatments. Suitable candidates for this trial include those with inoperable liver cancer who have not previously received Y90 radioembolization. As a Phase 1 trial, this research focuses on understanding how NP-101 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that NP-101 is likely to be safe for humans?

Research has shown that NP-101, derived from black seed (Nigella Sativa), has been safe in earlier studies. One study with Covid patients found that NP-101 was well-tolerated and helped boost certain immune cells (CD4+ and CD8+ T cells), which are crucial for fighting infections. This suggests NP-101 can be safe for humans.

Although this trial focuses on liver cancer, the previous Covid study provides some confidence about NP-101's safety. However, since this is the first trial for liver cancer, researchers will closely monitor for any side effects to determine the safest dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for liver cancer, like chemotherapy and targeted therapies, focus on stopping the growth of cancer cells but often come with significant side effects. NP-101 is unique because it offers a new approach, potentially working with the body's natural defenses to target cancer cells more precisely. Researchers are excited about NP-101 because it could provide a more effective treatment with fewer side effects. The treatment also comes in different doses (3 g, 4.8 g, and 6 g), allowing for tailored therapy that can be adjusted based on patient needs and responses. This flexibility, alongside its novel mechanism of action, gives NP-101 an edge over current liver cancer treatments.

What evidence suggests that NP-101 might be an effective treatment for liver cancer?

Research has shown that NP-101, which participants in this trial will receive in varying dosages, has promising effects on the immune system and cancer in early studies of liver cancer. In a previous study with Covid patients, NP-101 was safe and increased T effector cells, which are white blood cells important for fighting infections. This finding suggests that NP-101 might help the body fight cancer cells. By boosting these immune cells, NP-101 could improve outcomes for liver cancer patients, especially when combined with treatments like radioembolization. While more research is needed, these early results are encouraging for NP-101 in treating liver cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Ali Zarrinpar, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 with unresectable hepatocellular carcinoma (HCC) who can't have surgery or a liver transplant. They must be in good physical condition, have certain blood cell counts within range, and agree to provide tissue samples for research.

Inclusion Criteria

My liver cancer cannot be removed by surgery or treated with a liver transplant.

I am fully active or can carry out light work.

Your hemoglobin level is at least 9 grams per deciliter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NP-101 with dose escalation based on a Bayesian Optimal Interval design to determine the maximum tolerated dose

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

172 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NP-101

Trial Overview The study tests different doses of NP-101, an immune-modulating drug derived from black seed, in patients with HCC undergoing Y-90 treatment. It aims to find the highest dose that doesn't cause too many side effects (maximum tolerated dose).

How Is the Trial Designed?

Group I: NP-101 (6 g) Experimental Treatment 1 Intervention

Group II: NP-101 (4.8 g) Experimental Treatment 1 Intervention

Group III: NP-101 (3 g) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Novatek

Collaborator

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06217094

NCT06217094 | Study of NP-101 in Patients With ... This study will investigate the safety, efficacy and maximum tolerated dose of NP-101 in patients with unresectable hepatocellular carcinoma.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7539784/

Recent progress in treatment of hepatocellular carcinoma - PMC It had a 5-year overall survival (OS) rate of 60-70% [11]. Recent reports have shown that HR is an appropriate treatment for many patients with advanced disease ...

3. rarediseaseadvisor.com rarediseaseadvisor.com/hcp-resource/hepatocellular-carcinoma-clinical-trials/

Hepatocellular Carcinoma Clinical Trials A phase 1/2 clinical trial is assessing the safety and tolerability of TTI-101, a first-in-class, orally bioavailable small molecule inhibitor ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589555925002538

Hepatocellular Carcinoma: Epidemiology, diagnosis and ... Advances in surgical resection, liver transplantation, and locoregional therapies have improved outcomes in early and intermediate stages. In ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233051

The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy ... The technique efficacy at 30 days of 83% (30 of 36) achieved in a single procedure is like those achieved in the earliest reports of ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06217094/

Trial | NCT06217094 In a randomized phase 2 study conducted in Covid patients, NP-101 exhibited safety and significantly increased T effector cells (CD4+ and CD8+ T lymphocytes), ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9244967/

Immunotherapy for advanced hepatocellular carcinoma With a 5-year survival rate of less than 20%, liver cancer carries one of the worst cancer prognoses after pancreatic cancer[7]. Although this figure represents ...