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A study to evaluate the safety and effectiveness of BO-112 injections in patients with resectable primary basal cell carcinoma.

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What is this trial about?

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

This study focuses on Basal cell carcinoma, which is a common type of skin cancer. The research examines patients who have tumors that can be surgically removed, categorized as either low risk or high risk. The investigation aims to evaluate the effectiveness and safety of a treatment called BO-112, which is composed of the substance polyinosinic:polycytidylic acid. This medication is provided as a solution for injection and is administered through intratumoral use, meaning the medicine is injected directly into the tumor.

Participants in this study will receive injections of the study drug into their skin lesions. During the course of the trial, the response to the treatment will be observed through visual changes and pathological examination, which involves looking at tissue samples under a microscope to check for cancer cells. The study also monitors for any side effects or health issues that may occur during or after the treatment process.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>Injection</b> of the test substance

    A substance called BO-112, which contains polyinosinic:polycytidylic acid, is administered directly into the basal cell carcinoma (a type of skin cancer) through an injection into the lesion (the affected area).

    The dose for this injection is 2 mg.

  2. Step 2

    <b>Evaluation</b> of treatment response

    The effectiveness of the treatment is assessed through visual inspection and pathological examination (looking at tissue samples under a microscope) during surgery.

    The visual response is monitored during the study and at the time of surgery.

    The pathological response is evaluated by both the local doctor and a central review team.

  3. Step 3

    <b>Monitoring</b> for safety and recurrence

    The occurrence of adverse events (side effects or unexpected medical issues) is tracked, including any serious adverse events.

    The presence of recurrence (the return of the skin cancer) is monitored for 12 months following the surgery.

Who can join the trial?

9 criteria

  • You must be at least 18 years old.
  • You must have basal cell carcinoma, which is a common type of skin cancer, that is resectable, meaning it can be surgically removed.
  • You must have a biopsy result available for all skin areas being treated. A biopsy is a medical procedure where a small piece of skin is removed and examined under a microscope to confirm the diagnosis.
  • Your organ function, such as how well your heart, liver, or kidneys are working, must be healthy enough according to the study rules.
  • Women who are able to become pregnant must have a negative pregnancy test (testing for a hormone called HCG) within 24 hours before receiving the first dose of the study drug.
  • Women who can become pregnant must agree to use two effective forms of birth control during the study and for 4 weeks after the last treatment. These must include a barrier method (like a condom with spermicide) plus another method, such as oral contraceptives (birth control pills), an implant, an injection, or having tubal ligation (a permanent procedure to prevent pregnancy).
  • Men who have female partners who can become pregnant must agree to use two reliable methods of birth control during the study and for 4 weeks after the study ends.
  • You must be able to provide informed consent, which means you understand the study details and sign a document agreeing to participate.
  • You must be willing to follow all study rules, including having the treated skin area surgically removed once the study is finished.

Who cannot join the trial?

16 criteria

  • You cannot participate if your skin cancer lesions are in an area that received radiation therapy (a treatment using high-energy rays to kill cancer cells) within the last 6 months.
  • You cannot participate if your skin cancer lesions are located within 2 cm of the edge of your eyelid.
  • You cannot participate if you have any medical reasons that prevent you from undergoing surgery.
  • You cannot participate if you have Gorlin’s syndrome, which is a rare genetic condition that causes many skin tumors to grow.
  • You cannot participate if you have active or uncontrolled skin diseases or tattoos that might make it difficult for doctors to see and judge the area around the skin cancer.
  • You cannot participate if you have another type of malignant disease (cancer) that requires treatment, with some specific exceptions for very early-stage cancers that are being watched or have been fully treated.
  • You cannot participate if you have a history of immunological disorders (problems with the body's immune system), severe allergies, moderate to severe asthma, or a history of anaphylaxis (a severe, life-threatening allergic reaction).
  • You cannot participate if you are allergic to the study drug BO-112 or any of its excipients (the inactive substances used to carry the medicine).
  • Female participants cannot participate if they are pregnant or lactating (breastfeeding).
  • You cannot participate if you have received a live vaccine or an mRNA COVID vaccine within 7 days before the first dose, or if you plan to get a vaccination within 7 days after the last dose.
  • You cannot participate if you are immunocompromised, which means your body's ability to fight off infections is weakened.
  • You cannot participate if you have used systemic anti-lesion therapy (medicine that travels through the whole body to treat a spot) on the target lesions, or if you have had chemotherapy or immunotherapy (treatments that use the immune system to fight cancer) for another cancer within the last 24 months.
  • You cannot participate if you are currently receiving or have recently received other anti-cancer therapies, such as radiotherapy (using radiation to treat cancer) or investigational therapies (treatments being studied in research), within 28 days of the study.
  • You cannot participate if you have used any experimental agents (drugs being tested in research) within one month of the first injection.
  • You cannot participate if you have received or plan to receive psoralen plus UVA or UVB therapy (a light-based treatment used for certain skin conditions) within the last 6 months.
  • You cannot participate if you use topical products (creams or ointments applied to the skin) within 5 cm of the skin cancer or use body medicines that might interfere with how doctors evaluate the study drug.
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Investigated drugs

BO-112 is an experimental treatment that is injected directly into a tumor. It is designed to help the body's immune system recognize and fight against certain types of skin cancer.

What is already known about the treatment

BO-112 - This medication is an injection administered directly into a tumor to treat skin cancer. It is a substance currently being studied in clinical research for its ability to help the body fight certain types of cancer. As a biological modifier, it works by mimicking a viral infection to alert and activate the body's natural immune system to attack the cancer cells.

Investigated diseases

Basal cell carcinoma - This is a type of skin cancer that begins in the basal cells, which are located at the bottom of the outer layer of the skin. It often develops as a small, pearly bump or a flat, flesh-colored lesion. The condition typically grows slowly on sun-exposed areas of the body. As it progresses, it can expand into the surrounding skin tissue. It generally stays localized to the site where it first appeared.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511801-51-00Protocol codeBOT-112-204Estimated enrolment60 patientsSponsorHighlight Therapeutics S.L.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).