NG-641 for Advanced Cancer

(STAR Trial)

Recruiting at 5 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

186 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called NG-641 to see if it is safe for patients with advanced or spreading epithelial tumors. The treatment is given through an IV, and researchers are trying to find the best dose.

Research Team

Haesong Park, MD

Principal Investigator

Washington University School of Medicine, St Louis, Missouri

Eligibility Criteria

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

Treatment Details

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.

Participant Groups

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+