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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Highlight Therapeutics S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

24 Oct 2024 → ongoing

Decision date (initial)

2024-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Highlight Therapeutics S.L.

External identifiers

EU CT number

2024-511801-51-00

WHO UTN

U1111-1306-8484

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate efficacy of BO-112 administered by IL injection in patients with resectable primary low or high risk BCC, respectively

Secondary objectives 3

1. To evaluate safety and tolerability of BO-112 administered by IL injection in patients with resectable primary low or high risk BCC, respectively
2. To evaluate efficacy of BO-112 administered by IL injection in patients with resectable primary low or high risk BCC, respectively
3. To evaluate the recurrence rate of nodular BCC in patients with resectable primary low or high risk BCC, respectively

Conditions and MedDRA coding

Basal cell carcinoma

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

IPD plan description

Not yet determined

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Must be ≥ 18 years old
2. Has primary resectable low or high risk basal cell carcinoma according to the protocol definition
3. Has diagnostic punch biopsy or incisional biopsy of all lesions intended for injection available prior to the first dose of BO-112
4. Has adequate organ function as defined in the protocol
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
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

Exclusion criteria 15

1. Has any BCC lesion(s) planned for injection in site of prior radiation within 6 months prior to the first dose of BO-112 or has any BCC lesion(s) planned for injection within 2 cm of the open eyelid margins
2. Female participants: lactating or pregnant
3. Has received a live vaccine or mRNA 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
4. Is immunocompromised
5. Has any prior systemic anti-lesion therapy 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
6. 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.
7. Has any experimental or investigational agents within one month of first BO-112 injection
8. Has received or is expected to receive treatment with psoralen plus UVA or UVB therapy within 6 months prior to the first dose of BO-112
9. 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
10. Has any medical contraindications to surgery
11. Has Gorlin’s syndrome
12. Has clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target lesion
13. Has another malignant disease requiring treatment, except for adequately treated carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention other than hormonal therapy, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms
14. 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
15. Has history of hypersensitivity to BO-112 or its excipients/vehicle

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite visual and pathological response [at surgery] on patient level assessed by central review

Secondary endpoints 3

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. Visual response [during the study and at surgery] on patient level assessed by the investigator and central review, respectively.
3. Recurrence [at 12 months] after surgery on patient level assessed by the investigator

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Highlight Therapeutics S.L.

Sponsor organisation

Highlight Therapeutics S.L.

Address

Calle De San Agustin 9

City

Paterna

Postcode

46980

Country

Spain

Scientific contact point

Organisation

Highlight Therapeutics S.L.

Contact name

Marisol Quintero

Public contact point

Organisation

Highlight Therapeutics S.L.

Contact name

Marisol Quintero

Sponsor responsibilities

Article 77 compliance

Highlight Therapeutics S.L.

Contact point sponsor

Highlight Therapeutics S.L.

Article 77 implementation

Highlight Therapeutics S.L.

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications