NG-641 for Advanced Cancer

(STAR Trial)

No longer recruiting at 6 trial locations

Overseen By Akamis Bio

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PsiOxus Therapeutics Ltd

Must not be taking: Antivirals, Immunosuppressants, Vaccines

Disqualifiers: Transplantation, Active infections, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called NG-641 for individuals with advanced epithelial cancer that has either returned after treatment or lacks standard treatment options. Participants will receive NG-641 through an intravenous (IV) line to assess how their body handles it and whether it causes any side effects. The trial seeks individuals with advanced or metastatic epithelial cancer who have measurable disease and a tumor accessible for biopsy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires stopping certain medications before starting, like specific antiviral agents and some cancer treatments. However, bisphosphonate therapy for bone disease is allowed. It's best to discuss your current medications with the trial team to see if any need to be paused.

Is there any evidence suggesting that NG-641 is likely to be safe for humans?

Research has shown that NG-641 is under study for safety in patients with advanced or spreading epithelial tumors. Early results suggest that NG-641, which targets tumors, has a manageable safety profile, meaning any reported side effects are considered tolerable.

As a Phase 1 trial, the primary goal is to determine the treatment's safety and tolerability. Although detailed information on side effects is not yet available, the trial's progression to this stage indicates that early tests did not reveal major safety concerns. Participants in Phase 1 trials receive close monitoring, and researchers carefully manage any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for advanced cancer, which often includes chemotherapy, radiation, or immunotherapy, NG-641 is unique because it uses a novel mechanism of action. NG-641 is an oncolytic virus, which means it targets and destroys cancer cells while sparing healthy ones. Researchers are excited about this treatment because it not only directly attacks tumors but also stimulates the immune system to recognize and fight cancer, potentially offering a dual-action approach. This innovative delivery method via intravenous administration allows for precise targeting, which could lead to fewer side effects compared to traditional treatments.

What evidence suggests that NG-641 might be an effective treatment for advanced cancer?

Research has shown that NG-641 is a promising new treatment for advanced cancer. NG-641 specifically targets cancer cells. Early studies suggest it may help the immune system recognize and attack these cells. Although this treatment remains in the early testing stages, it aims to enhance the body's defenses against cancer. This trial focuses solely on NG-641, without combining it with other drugs like nivolumab. ^{1 3 4 6 7}

Who Is on the Research Team?

Haesong Park, MD

Principal Investigator

Washington University School of Medicine, St Louis, Missouri

Are You a Good Fit for This Trial?

This trial is for adults with advanced epithelial cancers that have failed standard treatments or have no standard options left. Participants must be expected to live at least 6 months, have tumors that can be biopsied safely, and function well in daily life (ECOG status 0-1). They should not have had certain vaccines, major surgeries, or specific treatments recently and must not have active infections or severe autoimmune diseases.

Inclusion Criteria

Your doctors believe you have at least 6 months or more to live.

All patients

Provide written informed consent to participate

Exclusion Criteria

Treatment with any live, live-attenuated or COVID-19 vaccine in the 28 days before the first dose of NG-641

Lymphangitic carcinomatosis

Any known CTCAE Grade ≥2 coagulation abnormality/coagulopathy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Treatment

Dose-escalation and dose-optimization phase with NG-641 administration by IV infusion

Up to 8 cycles

Phase 1b Treatment

Investigation of optimized multicycle dosing regimen as monotherapy in specific tumour types

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NG-641

Trial Overview The trial is testing NG-641, a new type of therapy designed to target cancer cells selectively. It's the first time this treatment is being used in humans. The main goal is to see how safe it is and how well patients tolerate it when given to those with metastatic or advanced epithelial tumors.

How Is the Trial Designed?

Group I: Intravenous Experimental Treatment 1 Intervention

Phase 1a dose escalation: one cycle of treatment. Phase 1a dose optimisation: up to 8 cycles of treatment

Who Is Running the Clinical Trial?

PsiOxus Therapeutics Ltd

Lead Sponsor

Trials

12

Recruited

790+

Akamis Bio

Lead Sponsor

Trials

13

Recruited

820+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04053283

NCT04053283 | First in Human Study With NG-641, a ... Study Overview. Brief Summary. To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS2682

NEBULA: A multicenter phase 1a/b study of a tumor- ... NEBULA (NCT05043714) is an open-label, dose-escalating, phase 1a/b study of NG-641 + nivolumab in patients (pts) with advanced/metastatic epithelial tumors.

3. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/CT214/704436/Abstract-CT214-A-multicenter-phase-1a-b-study-of

A multicenter phase 1a/b study of NG-641, a tumor-selective ... A multicenter phase 1a/b study of NG-641, a tumor-selective transgene-expressing adenoviral vector, and nivolumab in patients with metastatic or advanced ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-09947

Study of NG-641 in Combination With Nivolumab ... This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab (or standard of care PD-1 inhibition) in ...

5. researchgate.net researchgate.net/publication/365215403_762_First-in-human_phase_1a_study_of_NG-641_a_tumour-selective_vector_expressing_a_FAP-TAc_bispecific_antibody_and_immune_enhancer_module_in_patients_with_metastaticadvanced_epithelial_tumours_STAR

762 First-in-human phase 1a study of NG-641, a tumour- ... A multicenter phase 1a/b study of NG-641, a tumor-selective transgene-expressing adenoviral vector, and nivolumab in patients with metastatic or ...

6. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A794

762 First-in-human phase 1a study of NG-641, a tumour- ... STAR (NCT04053283) is a Phase 1 study of NG-641 in patients with metastatic/advanced epithelial tumours and no standard treatments.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8666888/

a phase 1 clinical trial - PMC - PubMed Central Enadenotucirev, a tumor-selective and blood stable adenoviral vector, has demonstrated a manageable safety profile in phase 1 studies in epithelial solid ...