NG-641 + Nivolumab for Advanced Cancer

(NEBULA 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)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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 patients with metastatic or advanced epithelial tumours. The purpose is to characterize the safety and tolerability of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours and to determine the recommended dose of NG-641 in combination with nivolumab for further development in patients with metastatic or advanced epithelial tumours

Research Team

Christian Ottensmeier, MD

Principal Investigator

Clatterbridge Cancer Centre

Eligibility Criteria

Adults over 18 with advanced epithelial cancer that's resistant to standard treatments or without treatment options. They must have a life expectancy of at least 6 months, good organ function, and be able to follow study procedures. Exclusions include severe bleeding risks, recent other cancer therapies, certain vaccinations close to trial start, active severe infections or autoimmune diseases.

Inclusion Criteria

Predicted life expectancy of ≥6 months

Meeting reproductive status requirements

My cancer has returned or didn't respond to treatment, and there's no standard treatment left.

Exclusion Criteria

I have a significant blood clotting disorder.

I have received certain vaccines within a specific timeframe.

I haven't had severe bleeding or related hospital visits in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Part A Treatment

One cycle (28 days) of NG-641 on Days 1, 3, and 5 and nivolumab on Day 15, followed by nivolumab every 4 weeks

4 weeks

Phase 1a Part B Treatment

NG-641 on Days 1, 3, and 5 and nivolumab on Day 15 in each of up to eight 28-day cycles

32 weeks

Phase 1b Treatment

Further investigation of the efficacy and safety of the selected dose regimen in up to three tumour types

Variable, based on cohort design

Follow-up

Participants are monitored every 8 weeks until 12 months from first dose for disease status, overall survival, further cancer therapy, and best response

12 months

Treatment Details

Interventions

• NG-641 in combination with Nivolumab

Trial Overview The trial is testing NG-641 in combination with Nivolumab for patients with metastatic or advanced epithelial tumors. It aims to find the safest dose and see how well patients tolerate this combo therapy. The study is early stage (phase 1a/1b), open-label and not randomized.

Participant Groups

Group I: Intravenous Experimental Treatment 1 Intervention

Phase 1a Part A: One cycle (28 days) of NG-641 on Days 1, 3 and 5 and nivolumab on Day 15, followed by nivolumab every 4 weeks. Phase 1a Part B: NG-641 on Days 1, 3 and 5 and one nivolumab on Day 15 in each of up to eight 28-day cycles.

Who Is Running the Clinical Trial?

PsiOxus Therapeutics Ltd

Lead Sponsor

Trials

12

Recruited

790+

Akamis Bio

Lead Sponsor

Trials

13

Recruited

820+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania