Phase 1 Study of NG-641 with Nivolumab and Pembrolizumab in Patients with Metastatic or Advanced Epithelial Tumors

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What is this study about?

The study focuses on people with metastatic cancer that started in the lining cells of organs, known as epithelial tumours. The treatment being tested combines an experimental medicine called NG-641, which uses a harmless virus to carry therapeutic material directly to the tumor, with an approved immunotherapy drug named nivolumab. Immunotherapy works by helping the body’s own immune system recognize and attack cancer cells, and the virus‑based approach is designed to make the tumor more visible to the immune system. Both medicines are given through an IV (a needle placed in a vein) so they travel directly into the bloodstream.

The main goal of the trial is to find out how safe the combination is and what dose can be used for further research.

During the study, participants receive a series of IV infusions of the two medicines over several weeks, with regular visits to check for any side effects and to monitor overall health. The schedule may include a few visits each month at the start and then less frequent check‑ins as treatment continues, allowing doctors to observe how the body responds over time.

1 baseline assessment

after you join the study, you will have a baseline visit where the study team will record your medical history, perform physical examinations, and collect blood samples.

imaging tests such as CT or MRI scans will be done to document the size and location of your tumours.

2 first infusion of study drugs

on the first treatment day you will receive ng-641, a suspension that is given by intravenous infusion. the dose is 3 ml per infusion.

you will also receive nivolumab, a medication that blocks the pd-1 protein to help your immune system attack cancer cells. the dose is 480 mg and it is also given by intravenous infusion.

3 immediate monitoring after infusion

after each infusion you will be observed for several hours. vital signs such as heart rate, blood pressure, and temperature will be checked regularly.

any signs of an allergic reaction or other immediate side effects will be recorded.

4 subsequent treatment cycles

you will return for additional cycles of the two drugs according to the schedule defined by the study protocol. each cycle includes another infusion of ng-641 (3 ml) and nivolumab (480 mg).

before each cycle blood tests will be performed to assess organ function and to detect any new safety concerns.

5 periodic tumour assessments

at specified intervals imaging scans will be repeated to evaluate how your tumours are responding to the treatment.

the results will be compared with the baseline scans to determine whether the tumours have shrunk, remained stable, or grown.

6 ongoing safety monitoring

throughout the study you will be asked to report any new symptoms, such as fatigue, fever, rash, or breathing difficulties.

regular laboratory evaluations will continue to monitor for possible side effects affecting the liver, kidneys, blood cells, or other organs.

7 end of treatment

treatment will stop after the predefined number of cycles, if the disease progresses, or if side effects become unacceptable.

the study team will document the reason for stopping treatment.

8 follow‑up visits

after treatment ends you will have scheduled follow‑up visits to check your overall health, record any late side effects, and assess survival.

these visits may include physical examinations, blood tests, and imaging studies performed at intervals defined by the study protocol.

Who Can Join the Study?

Have a confirmed diagnosis of metastatic (cancer that has spread) or advanced epithelial cancer confirmed by laboratory tests that look at tissue (histology) or cells (cytology).
Have at least one tumor that can be measured using the standard imaging rules called RECIST v1.1 (a system doctors use to track tumor size).
Be able to give written informed consent (sign a form agreeing to join the study after understanding it).
Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to do light work but limited in strenuous activity (1).
Be 18 years of age or older on the day you sign the consent form.
Have a tumor that can be reached for a biopsy (a small tissue sample taken for testing).
Both men and women are eligible to take part.

Who Cannot Join the Study?

Having had or planning to have a bone‑marrow, tissue, or organ transplant, whether from another person (allogeneic) or from your own body (autologous)
Having had your spleen removed (splenectomy)
Having an active infection that needs strong medicines, close doctor monitoring, a hospital stay, or having repeated fevers above 38 °C that are diagnosed as an infection within 20 days before the first study dose
Taking any of the antiviral medicines ribavirin, adefovir, lamivudine, cidofovir, or paxlovid within 10 days before the first study dose
Having a known history of hepatitis B infection, an active hepatitis C infection, or a known HIV infection
Having an autoimmune disease that required whole‑body (systemic) treatment in the past 2 years, being considered to have a weakened immune system (immunocompromised), or currently taking long‑term medicines that suppress the immune system (immunosuppressive treatment)
Receiving any live or live‑attenuated vaccine, including a COVID‑19 vaccine, within 30 days before the first study dose

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
HM Sanchinarro	Madrid	Spain
Cdrelksha Ufgbxqafytrmrs Snbruyzgl	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2023
Spain	Not recruiting	01.10.2023

Trial locations

Investigated Drugs:

NG-641 is an experimental therapy that uses a specially engineered virus to deliver a gene directly into tumor cells. The gene makes the cancer cells produce a signal that helps the body’s immune system recognize and attack them. It is given by a short intravenous infusion in a liquid suspension.

nivolumab (brand name OPDIVO) is an immunotherapy drug that blocks a protein called PD‑1 on immune cells. By blocking this protein, nivolumab “releases the brakes” on the immune system, allowing it to more effectively find and destroy cancer cells. It is administered through an intravenous infusion.

pembrolizumab (brand name KEYTRUDA) is also a PD‑1 blocking immunotherapy. Like nivolumab, it helps the immune system see and fight cancer by preventing the PD‑1 protein from turning off immune responses. It is delivered by intravenous infusion.

Investigated Diseases:

Metastatic neoplasm

Metastatic cancer – A cancer that has spread from its original location to other parts of the body. Cancer cells break away from the primary tumor, travel through the bloodstream or lymph system, and form new growths in distant organs. These secondary tumors continue to grow and can affect the function of the organs where they settle. The disease often progresses as more sites become involved over time.

Epithelial tumor – A growth that originates from the cells lining the surfaces of organs, glands, and skin. The tumor may start as a small mass that expands within the tissue where it began. As it enlarges, it can infiltrate nearby structures and sometimes break through tissue boundaries. Over time, the tumor can develop additional abnormal cells that may spread locally.

Trial ID:

2023-503525-19-00

Protocol code:

NG-641-03

NCT ID:

NCT05043714

Trial Phase:

Human Pharmacology (Phase I) – Other

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Phase 1 Study of NG-641 with Nivolumab and Pembrolizumab in Patients with Metastatic or Advanced Epithelial Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?