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

NCT06422936 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-26

No results posted yet for this study

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.

* primary endpoint is visual and pathological response \[at surgery\] on patient level 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.
3. Recurrence \[at 12 and 24 months\] after surgery on patient level assessed by the investigator.

Conditions

Interventions

DRUG

BO-112

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

Sponsors & Collaborators

  • Highlight Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2026-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • Israel
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422936 on ClinicalTrials.gov