Not recruiting

Phase 1 safety and dose-finding study of NG-350A plus pembrolizumab in patients with metastatic cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with metastatic cancer that originated from epithelial tumours. The treatment being investigated combines an immune‑boosting drug called pembrolizumab, given by infusion, with a new experimental agent named NG-350A, which is delivered as an injection and is designed to target cancer cells through a specific protein called CD40.

The purpose of the study is to evaluate how safe the combination is and to find the appropriate dose for future use.

Participants will receive the two medicines together in a series of treatment sessions that occur over several weeks. Throughout the study, they will have regular clinic visits where doctors will check for any side effects, perform blood tests, and use standard imaging scans to look at the tumors. The study will continue until the planned number of treatment cycles is completed or if the doctors decide to stop the treatment for safety reasons.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial enrollment visit
You attend the first study visit after agreeing to participate. during this visit, the study team records your medical history, performs a physical examination, and collects blood and imaging tests to establish a baseline for your condition.
Step 2
Baseline assessments completed
The results of the baseline tests are reviewed to confirm that you meet the study criteria. these assessments serve as reference points for later comparison of safety and response to the treatment.
Step 3
First administration of ng-350a
You receive an intravenous injection of ng-350a in a dose of 3 ml. the medication is given through a vein using a syringe. the injection is performed in the clinic under the supervision of the study staff.
Step 4
First infusion of pembrolizumab
Shortly after the ng-350a injection, you receive an infusion of pembrolizumab (brand name keytruda) at a dose of 400 mg. the drug is mixed as a solution for infusion and delivered slowly into a vein over a period of time.
Step 5
Immediate safety monitoring
Following each medication administration, you are observed in the clinic for a period of time. vital signs such as blood pressure, heart rate, and temperature are checked, and you are asked about any new symptoms. this monitoring helps identify any immediate side effects.
Step 6
Regular follow‑up visits
Throughout the study, you return to the clinic for scheduled visits. at each visit, the study team repeats safety assessments, collects blood samples, and may perform additional imaging to evaluate how the tumour is responding. the timing of these visits follows the study protocol.
If additional doses of ng-350a or pembrolizumab are required, they are given in the same manner as the first administration, using the same 3 ml injection for ng-350a and the 400 mg infusion for pembrolizumab.
Step 7
End‑of‑treatment evaluation
When the planned treatment period ends, you undergo a final set of assessments. these include a physical exam, laboratory tests, and imaging studies to determine the overall safety profile and any effect on the tumour.
The results are recorded, and you are informed about the next steps for continuing routine medical care.

Who can join the trial?

7 criteria

Have a diagnosis of metastatic or advanced epithelial cancer that has been confirmed by a tissue or cell test (called histology or cytology).
Have at least one tumor that can be measured on scans, using the standard rules called RECIST v1.1.
Sign a written form that shows you understand the study and agree to take part (written informed consent).
Be 18 years of age or older on the day you sign the consent form.
Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to do light work but not strenuous activity (1).
Have a tumor that can be reached safely to take a small sample for testing (biopsy).
Both men and women are eligible to join the study.

Who cannot join the trial?

7 criteria

People who have already had, or are planning to have, a bone‑marrow or organ transplant – whether the donor is another person (allogeneic) or themselves (autologous) – cannot join the study.
If you have had your spleen removed (splenectomy), you are not eligible.
Anyone with a current infection that needs medicine taken throughout the whole body (systemic anti‑infective treatment), needs close doctor monitoring or hospital stay, or who has had repeated fevers above 38 °C diagnosed as an infection within the 20 days before the first dose cannot participate.
People who have taken any of the following antiviral medicines – ribavirin, adefovir, lamivudine, cidofovir, or paxlovid – within 10 days before the first dose are excluded.
Those with a known past infection with hepatitis B, a current hepatitis C infection, or a known HIV infection are not allowed to join.
If you have an active autoimmune disease that required medicines affecting the whole body (systemic therapy) in the past two years, have a weakened immune system (immunocompromised) as judged by the doctor, or are taking long‑term medicines that suppress the immune system (immunosuppressive treatment), you cannot be enrolled.
Anyone who received any live vaccine, a weakened‑live vaccine (live‑attenuated), or a COVID‑19 vaccine within 30 days before the first dose is excluded.

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Verified sites

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Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium

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Investigated drugs

Keytruda
is a medicine that helps the body’s immune system see and attack cancer cells. It works by blocking a protein that can stop immune cells from attacking tumors, allowing the immune system to work more effectively against the cancer. In this study, Keytruda is given through an IV infusion together with another experimental therapy to test how safe they are when used together.
NG-350A
is an experimental treatment that uses a harmless virus engineered to carry a signal that activates a protein called CD40, which is found on many tumor cells. By delivering this signal directly to the tumor, NG-350A aims to boost the body’s immune response specifically against the cancer. It is given as an injection into a vein and is being tested in combination with Keytruda to see if the two together are safe and can work better against advanced cancers.

Pembrolizumab

What is already known about the treatment

Keytruda (pembrolizumab)
It is given as an intravenous infusion of a clear solution, usually over about 30 minutes. Pembrolizumab is an approved cancer medicine widely studied in many clinical trials. It is used mainly to treat various metastatic cancers, such as lung, skin and head‑neck tumors. It works by blocking the PD‑1 protein on immune cells, which helps the body’s immune system recognize and attack cancer cells; it belongs to the class of immune checkpoint inhibitors.
NG-350A
It is administered as a small volume (about 3 ml) suspension injected into a vein. NG-350A is an experimental adenoviral vector still in early phase‑1 trials and not yet approved for routine use. It is being tested for metastatic or advanced epithelial tumors. The vector carries a gene that activates CD40 on tumor cells, stimulating an immune response against the tumor; it is classified as a tumor‑selective gene‑therapy immunomodulator.

Investigated diseases

Epithelial carcinoma
A carcinoma is a cancer that starts in the thin layer of cells covering organs and glands. It usually begins as a small, localized growth in this lining. Over time the tumor can enlarge and push into surrounding tissues. If it continues to grow, it may spread beyond its original site.
Metastatic cancer
This term describes cancer that has moved from its original location to other parts of the body. Cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system. They then settle in new organs and form secondary tumors. The spread can involve many different organs, creating a more widespread disease.