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Phase 1 study of NG-641 plus nivolumab (or standard of care PD-1) in metastatic or advanced epithelial tumours (NEBULA)
EU CTIS ID: 2023-503525-19-00
What this study is testing
To characterise the safety and tolerability of NG-641 in combination with nivolumab (or standard of care PD1 inhibitor) in patients with metastatic or advanced epithelial tumours To determine the recommended dose of NG-641 in combination with nivolumab (or standard of care PD1 inhibitor) for further development in patients with metastatic or advanced epithelial tumours
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must have histologically or cytologically documented metastatic or advanced epithelial cancer
- At least one measurable site of disease according to RECIST v1.1
- Provide written informed consent to participate
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Aged 18 years or over on day of signing informed consent
- Tumour accessible for biopsy
You likely can't join if
- Prior or planned allogeneic of autologous bone marrow or tissue/organ transplant
- Splenectomy
- Active infections requiring systemic anti-infective treatment, physician monitoring/hospital admission or recurrent fevers (>38.0C) associated with a clinical diagnosis of active infection within 20 days of anticipated first dose of study drug
- Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment
- Known history of hepatitis B infection or known active hepatitis C infection, known history of HIV infection
- Patients who have autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving chronic systemic immunosuppressive treatment
See the full eligibility criteria
- Patients must have histologically or cytologically documented metastatic or advanced epithelial cancer
- At least one measurable site of disease according to RECIST v1.1
- Provide written informed consent to participate
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Aged 18 years or over on day of signing informed consent
- Tumour accessible for biopsy
- Prior or planned allogeneic of autologous bone marrow or tissue/organ transplant
- Splenectomy
- Active infections requiring systemic anti-infective treatment, physician monitoring/hospital admission or recurrent fevers (>38.0C) associated with a clinical diagnosis of active infection within 20 days of anticipated first dose of study drug
- Treatment with the antiviral agents: ribavirin, adefovir, lamivudine, cidofovir or paxlovid within 10 days prior to the first dose of study treatment
- Known history of hepatitis B infection or known active hepatitis C infection, known history of HIV infection
- Patients who have autoimmune disease that has required systemic therapy in the past 2 years, are immunocompromised in the opinion of the Investigator, or are receiving chronic systemic immunosuppressive treatment
- Treatment with any live, live-attenuated or COVID-19 vaccine in the 30 days before the first dose of study drug
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.