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Safety and Tolerability of Inhaled KB707 with or without Docetaxel in Patients with Advanced Lung Solid Tumors

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 people with advanced solid tumor cancers that have spread to the lungs. A solid tumor is a lump of abnormal cells that grows in an organ. The investigational medicine is an inhaled suspension called KB707. KB707 contains a harmless version of the herpes simplex virus that has been engineered to produce interleukin-12, a protein that encourages the immune system to fight cancer, and an antibody that blocks programmed cell death protein 1, a checkpoint that can keep immune cells from attacking tumors. The medicine is breathed in using a device, allowing it to reach the lungs directly. The study may also use standard cancer medicines such as the chemotherapy drug docetaxel given through a vein, or other drugs known as immune checkpoint inhibitors that help the immune system recognize cancer cells.

The main aim of the trial is to see how safe the inhaled KB707 is, both by itself and when combined with other treatments. Participants will receive the inhaled medicine in several treatment cycles, with each cycle lasting a few weeks. Some participants may also receive the additional chemotherapy or checkpoint drugs according to the study plan. Throughout the study, doctors will check for any side effects, record any problems, and perform routine health checks such as blood tests and imaging scans.

After the treatment period, participants will continue to be followed for several months to observe any long‑term effects and to see how the cancer behaves. Information collected will help determine whether the inhaled therapy can be used safely in future larger studies.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and consent
After joining the study, the patient undergoes screening tests to confirm eligibility, including medical history review and baseline examinations.
Written informed consent is obtained before any study procedures are performed.
Step 2
Baseline assessments
The patient receives baseline laboratory tests, imaging studies, and assessment of tumor status.
Baseline safety measures are recorded to compare with later observations.
Step 3
Start of treatment cycle
The first treatment cycle begins according to the study schedule.
The patient receives kb707 by inhalation as a suspension; the exact dose and frequency are defined by the protocol.
If the study arm includes combination therapy, the patient also receives docetaxel by intravenous infusion according to the protocol.
Step 4
Regular dosing during each cycle
The patient continues to receive kb707 inhalation on the schedule specified for the cohort, typically once per treatment day.
When combined with docetaxel, the infusion is administered on the days indicated by the protocol, often every three weeks.
The total duration of administration continues until disease progression, unacceptable toxicity, or completion of the planned number of cycles.
Step 5
Safety monitoring and assessments
The patient is evaluated for adverse events and serious adverse events at each visit.
Laboratory tests, vital signs, and symptom questionnaires are collected regularly to assess safety and tolerability.
Dose‑limiting toxicity is assessed according to predefined criteria.
Step 6
Efficacy evaluations
Imaging studies are performed periodically to determine tumor response, including objective response rate and progression‑free survival.
Clinical benefit and duration of response are recorded as part of secondary objectives.
Step 7
Treatment discontinuation
Treatment may be stopped if the patient experiences unacceptable toxicity, disease progression, or completes the planned treatment course.
The decision follows the criteria set in the study protocol.
Step 8
Follow‑up after treatment
The patient continues to be followed for survival and long‑term safety outcomes.
Periodic visits are scheduled to collect data on overall survival and any late adverse events.

Who can join the trial?

9 criteria

The patient (or a legally authorized representative) must read, understand, and sign a study consent form that has been approved by an Institutional Review Board (IRB) and must be willing to follow the study instructions.
You must be 18 years old or older when you sign the consent form.
You need to have a predicted remaining life span of more than 12 weeks.
Your overall health level, measured by the Eastern Cooperative Oncology Group (ECOG) performance status, must be 0 (fully active) or 1 (restricted in physically strenuous activity but able to do light work).
You must have at least one lung tumor that can be measured on a scan according to the RECIST v1.1 guidelines.
Your blood and kidney tests must show adequate organ function, including: white blood cell count (WBC) at least 2,000 per microliter, neutrophil count at least 1,500 per microliter, platelet count at least 100,000 per microliter, hemoglobin at least 9.0 g/dL, serum creatinine 2 mg/dL or lower (or a kidney filtration rate of 40 mL/min or higher), liver enzymes (AST and ALT) no more than three times the normal limit, and normal total bilirubin unless you have liver involvement from cancer or a condition called Gilbert’s syndrome (in which case bilirubin can be up to twice the normal limit).
You must have a tissue diagnosis confirming an advanced solid tumor that affects the lungs, and you must have either progressed after standard treatments, be unable to tolerate them, have refused them, or have no standard treatment options.
You must have a tissue or cell diagnosis confirming stage 3 or stage 4 non‑small cell lung cancer (NSCLC) according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
You must meet the study’s rules about previous cancer therapies: you may have received no more than one prior line of an immune checkpoint inhibitor (ICI) with or without platinum‑based chemotherapy, or no more than two prior lines if the ICI and platinum chemotherapy were given separately. If your tumor has an “actionable mutation” such as EGFR, KRAS, ALK, or ROS1, you are allowed one additional line of approved targeted therapy.

Who cannot join the trial?

12 criteria

You have not fully healed after previous surgery or radiotherapy, including any side effects (called toxicity) from the radiation.
You have been diagnosed with human immunodeficiency virus (HIV) or have a positive test for it.
You are pregnant, nursing (breastfeeding), or plan to become pregnant while taking the study drug and for three months after the last dose.
You are unwilling to follow the study’s contraception (birth‑control) requirements.
You have any other health problem that the doctor believes would make it difficult for you to complete the study procedures or could increase safety risks.
You have a history of not following study rules, or the doctor thinks you may not follow the study requirements.
You have another malignancy (cancer) that is getting worse or needs active treatment right now.
Cancer has spread to your brain (brain metastases) or to the thin layers covering the brain and spinal cord (leptomeningeal metastases).
You previously received an immunotherapy called anti‑PD‑1/PD‑L1 therapy and could not tolerate it, so the treatment had to be stopped.
You have an active, known, or suspected autoimmune disease (where the immune system attacks the body) that requires systemic treatment (medication that affects the whole body).
You have a known acute (recent) or chronic (long‑lasting) hepatitis (inflammation of the liver).
You have current pneumonitis (lung inflammation) or a history of lung inflammation caused by immune checkpoint inhibitor (ICI) therapy that required treatment with steroids.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

KB707
KB707 is a specially designed medicine that is inhaled as a thin liquid (a suspension) and delivered directly into the lungs. It uses a harmless version of the herpes simplex virus to carry two important components into the body: a protein called interleukin‑12 that helps boost the immune system’s ability to fight cancer, and an antibody that blocks a protein called programmed cell death protein 1 (PD‑1) which cancer cells often use to hide from the immune system. By delivering these agents straight to the lungs, KB707 aims to stimulate a strong local immune response against lung tumors while minimizing side effects elsewhere in the body. Docetaxel
Docetaxel is a chemotherapy drug that is given by an intravenous (IV) infusion. It works by stopping cancer cells from dividing and growing, which can help shrink tumors. In this study, docetaxel may be used together with KB707 to see if the combination is safe and if it improves how well the treatments work compared with each one alone. Immune checkpoint inhibitors
Immune checkpoint inhibitors are a type of medicine that helps the body’s own immune system recognize and attack cancer cells. They work by blocking signals (checkpoints) that normally keep the immune system from being too aggressive. By releasing these brakes, the drugs allow immune cells to better target and destroy tumor cells. In the trial, these inhibitors may be given together with KB707, with or without additional chemotherapy, to explore whether the combined approach is safe and effective for patients with advanced lung‑affecting solid tumors.

Docetaxel

What is already known about the treatment

DOCETAXEL
DOCETAXEL is given by intravenous infusion, meaning it is slowly injected into a vein. It is an approved chemotherapy drug that has been studied extensively and is used worldwide for many solid cancers such as breast, lung, and prostate tumors. The medicine belongs to the taxane class and works by locking the tiny tubes inside cells (microtubules) so the cancer cells cannot divide and grow. By stopping cell division, it helps shrink tumors and improve patient outcomes.
KB707
KB707 is inhaled as a liquid suspension that is breathed in, allowing the medicine to reach the lungs directly. It is an experimental treatment still in early clinical trials and not yet approved for general medical use. The therapy uses a harmless herpes virus to deliver two immune‑boosting proteins: interleukin‑12, which activates the body’s defense cells, and an antibody that blocks the PD‑1 checkpoint, helping the immune system attack cancer. This approach is classified as an oncolytic viral immunotherapy aimed at treating advanced solid tumors in the lungs.

Investigated diseases

Solid tumor - A solid tumor is a mass of abnormal cells that forms in organs or tissues such as the lung, breast, or colon. It grows by dividing and accumulating more cells, which can cause the mass to enlarge over time. As the tumor expands, it may press on nearby structures, leading to changes in organ function. The tumor can also develop new blood vessels to supply its growth. In some cases, cells from the tumor may detach and travel to other parts of the body, forming new growths. This process of spread is called metastasis.