AzTrials
AzTrials

Basal Cell CarcinomaPhase 2SPOTLIGHT204NCT06422936

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

A Phase 2 study testing BO-112 in people with Basal Cell Carcinoma, run by Highlight Therapeutics at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Basal Cell Carcinoma
What is being tested?
BO-112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
10 sitesin 2 countries
Study dates
27 May 2024to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Has primary resectable low or high risk basal cell carcinoma according to the protocol definition
  • Has diagnostic punch biopsy of all lesions intended for injection available prior to the first dose of BO-112.
  • Has adequate laboratory values as defined per protocol
  • Sex and Contraceptive/Barrier Requirements
Show all 12Show fewer
  • 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.
  • 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.
  • 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
  • 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.
  • Able and willing to comply with all study requirements, including surgical removal of lesion/lesion site at completion of study.

Who cannot join

  • Has history of hypersensitivity to BO-112 or its excipients/vehicle.
  • Has any BCC lesion(s) planned for injection in site of prior radiation within 6 months prior to first dose of BO-112.
  • Has any BCC lesion(s) planned for injection within 2 cm of the open eyelid margins
  • Has Gorlin's syndrome
  • Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion
  • Has another malignant disease requiring treatment
Show all 16Show fewer
  • 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.
  • Female participants: lactating or pregnant.
  • 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.
  • Is immunocompromised. Systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to the first dose of BO-112.
  • 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.
  • Has any experimental or investigational agents within one month of first BO-112 injection.
  • 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.
  • 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.
  • 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.
  • Has any medical contraindications to surgery

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Spain6 sites

  • Hospital Clínic Barcelona

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao, 48013

  • Clínica Universitaria de Navarra (CUN)

    Madrid, 28027

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • Instituto Valenciano de Oncología (IVO)

    Valencia, 46009

Other trials in Spain

Israel4 sites

  • Soroka Medical Center

    Beersheba

  • Rambam Medical Center

    Haifa

  • Hadassah Ein Kerem Medical Center

    Jerusalem

  • Kaplan Medical Center

    Rehovot, 7661041

Other trials in Israel

About this study

Official title: 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.
Read the 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.

Being tested
BO-112
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BO-112Drug

    Noncoding double-stranded (ds) RNA based on polyinosinic-polycytidylic acid (Poly I:C), formulated with polyethylenimine (PEI) for intra-lesional injection

Study groups in NCT06422936
Study groupRoleWhat they receive
Cohort IExperimentalpatients with low risk nodular and/or low risk superficial BCC
Receives: Drug: BO-112
Cohort IIExperimentalpatients with high risk BCC
Receives: Drug: BO-112

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Visual and Pathological Response

    The composite primary endpoint of the visual and pathological response is defined as visual and pathological response on patient level.

    Measured: at surgery

Secondary outcomes (3)

  1. Number of Participants with Treatment-Related Adverse Events assessed by CTCAE 5.0

    Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on participant level.

    Measured: through study completion, average 7 months

  2. Extent of Pathological Response

    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

    Measured: at surgery

  3. Change of Visual Lesion Appearance

    Visual response [during the study and at surgery] on participant level assessed by the investigator and central review, respectively.

    Measured: at baseline and at surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start27 May 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel group design with same treatment and study procedures
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422936
Sponsor's protocol ID
BOT-112-204
Acronym
SPOTLIGHT204
Status last verified
Sep 2026
First submitted
13 May 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BO-112 in people with Basal Cell Carcinoma, run by Highlight Therapeutics at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Visual and Pathological Response (time frame: at surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06422936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in