Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC) (SPOTLIGHT204)

September 15, 2026 updated by: Highlight Therapeutics

SPOTLIGHT 204: A Multicenter, Phase 2b, Open-label, Non-randomized, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients With Resectable Primary Low and High Risk Basal Cell Carcinoma

This is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability, pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma.

  • primary endpoint is composite visual and pathological response [at surgery] on patient level as assessed by central review

  • secondary endpoints are

    1. Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level.
    2. Pathological response [at surgery] on patient level assessed by the investigator and central review, respectively, and visual response [during the study and at surgery] on patient level assessed by the investigator and central review, respectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted in patients with resectable primary low- and high-risk basal cell carcinoma according to the following definition:

Low-risk nodular BCC and/or low-risk superficial BCC:

• Participants with primary resectable nodular and/or superficial BCC with well-defined borders with:

  • At least one lesion with the longest diameter from 5 to 10 mm located on cheeks, forehead, scalp, neck, and pretibial. OR
  • At least one lesion with the longest diameter from 5 to 20 mm located on trunk and extremities (excluding hands, feet, nail units, pretibial, and ankles).

High-risk BCC:

  • Participants with primary resectable aggressive BCC (i.e. having morpheaform, basosquamous (metatypical), sclerosing, mixed infiltrative, or micronodular features in any portion of the lesion) with:

    • At least one lesion with the longest diameter from 5 mm to 30 mm in any body location. OR

  • Participants with primary resectable nodular and/or superficial BCC with

    • At least one lesion with the longest diameter from 5 mm to 30 mm located on central face, nose, lips, chin, mandible, preauricular and postauricular skin/sulci, temple, ear, genitalia, hands, and feet OR
    • At least one lesion larger than 10 mm to 30 mm located on cheeks, forehead, scalp, neck, and pretibial OR
    • At least one lesion larger than 20 mm to 30 mm located on trunk and extremities.

For all participants: lesion(s) intended to be injected must be at least 2 cm apart from the open eyelid margins.

Participants with multiple lesions in both groups must have a diagnostic punch or incisional biopsy from all lesions intended for injection and all lesions intended for injection must be resectable and injectable.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Beersheba, Israel
        • Soroka Medical Center
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Ein Kerem Medical Center
      • Rehovot, Israel, 7661041
        • Kaplan Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28027
        • Clínica Universitaria de Navarra (CUN)
      • Salamanca, Spain, 37007
        • Complejo Asistencial Universitario de Salamanca
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología (IVO)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant must be ≥ 18 years old [or the legal age of consent in the jurisdiction in which the study is taking place], at the time of signing the informed consent.

    Type of Participant and Disease Condition

  2. Has primary resectable low or high risk basal cell carcinoma according to the protocol definition
  3. Has diagnostic punch biopsy of all lesions intended for injection available prior to the first dose of BO-112.

  4. Has adequate laboratory values as defined per protocol

    Sex and Contraceptive/Barrier Requirements

  5. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug.
  6. Women of childbearing potential must be willing to use two effective methods of birth control while treated with BO-112 and for 4 weeks after the last treatment. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives from the time of informed consent.

  7. Male patients with female partners of childbearing potential must be willing to use two adequate contraception methods while treated with BO-112 and for 4 weeks after treatment completion.

    Informed Consent

  8. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  9. Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of study.

Exclusion Criteria:

  1. Has history of hypersensitivity to BO-112 or its excipients/vehicle.
  2. Has any BCC lesion(s) planned for injection in site of prior radiation within 6 months prior to first dose of BO-112.
  3. Has any BCC lesion(s) planned for injection within 2 cm of the open eyelid margins
  4. Has Gorlin's syndrome
  5. Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion
  6. Has another malignant disease requiring treatment
  7. Has a history of immunological disorder, severe allergic reaction, moderate or severe asthma or known history of anaphylaxis or any other serious adverse reactions to the investigational products.
  8. Female participants: lactating or pregnant.
  9. Has received a live vaccine or messenger ribonucleic acid (mRNA) Corona virus disease (COVID) vaccine within 7 days prior to the first dose of study drug or has a vaccination planned during treatment with BO-112 and within 7 days after the last study drug administration.
  10. Is immunocompromised. Systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to the first dose of BO-112.
  11. Has any prior systemic anti-lesion therapy or local treatment for study lesions prior to first dose; any chemotherapy or immunotherapy for any other malignancy within 24 months prior to the first dose of BO-112.
  12. Has any experimental or investigational agents within one month of first BO-112 injection.
  13. Has received or is expected to receive treatment with psoralen plus ultraviolet A (UVA) or ultraviolet B (UVB) therapy within 6 months prior to the first dose of BO-112.
  14. Requires / or has used topical products within 5 cm of a treatment-targeted BCC lesion or systemic therapies that might interfere with the evaluation of the study medication during the study.
  15. Has any other concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational [used for a not approved indication and in the context of a research investigation]) within 28 days of first study drug administration; or plans to participate in an experimental drug study while enrolled in this study.
  16. Has any medical contraindications to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort II
patients with high risk BCC
Drug: BO-112
Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection
Experimental: Cohort I
patients with low risk nodular and/or low risk superficial BCC
Drug: BO-112
Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Visual and Pathological Response
Time Frame: at surgery
The composite primary endpoint of the visual and pathological response is defined as visual and pathological response on patient level.
at surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Related Adverse Events assessed by CTCAE 5.0
Time Frame: through study completion, average 7 months
Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on participant level.
through study completion, average 7 months
Extent of Pathological Response
Time Frame: at surgery

Pathological response on participant level assessed by the investigator and central review, respectively, using a 4-point scale

  1. Pathologic Complete Response (pCR): No Residual Viable Tumor (RVT)
  2. Major Pathologic Response (MPR)/ "near-pCR": <= 10% RVT
  3. Pathologic Partial Response (pPR): 10% < RVT <= 50% "
  4. Pathologic Non-Response" (pNR): >50% RVT
at surgery
Change of Visual Lesion Appearance
Time Frame: at baseline and at surgery
Visual response [during the study and at surgery] on participant level assessed by the investigator and central review, respectively.
at baseline and at surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Highlight Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BOT-112-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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