186 Participants Needed

NG-641 for Advanced Cancer

(STAR Trial)

Recruiting at 5 trial locations
PT
AB
Overseen ByAkamis Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

HP

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
See 10 more

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
See 27 more

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?
1Treatment groups
Experimental Treatment
Group I: IntravenousExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PsiOxus Therapeutics Ltd

Lead Sponsor

Trials
12
Recruited
790+

Akamis Bio

Lead Sponsor

Trials
13
Recruited
820+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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