A Phase 1/2a, First-In-Human, Single and Multiple Ascending Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Intralesional FLD-103 in Subjects with Basal Cell Carcinoma (BCC)

ACTRN 12624001138572

Brief Summary

This study aims to determine the safety, tolerability and pharmacokinetics of intralesional FLD-103 when administered to subjects with Basal Cell Carcinomacancer arising from tissues that line organs.

Intervention/Treatment

• Drug: FLD-103

Inclusion Criteria

1. At least 18 years of age and up to 85 years of age, inclusive, at the time of signing the informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
2. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and is willing and able to return for all study visits and comply with all protocol requirements and procedures.
3. At Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening, the subject must have at least a single histologically confirmed nBCC suitable for treatment and final excisionto surgically remove/cut out by the Investigator.
4. A nBCC previously biopsied outside the study as part of standard clinical practice may be re-biopsied within the study, provided that less than 25 percent of the area of the nodular lesion is removed as a result of the second biopsyremoval of a section of tissue to analyse for cancer cells.
5. If no previous biopsy is available, target nBCC must be appropriate for a full thickness 2 mm punch biopsy (for lesions from 5 mm up to less than 10 mm diameter) or preferrably a 3 mm punch biopsy (for lesions from 10 mm to less than 20 mm diameter), taken approximately halfway from the centre or outer border of each target nBCC, within 14 to 42 days prior to Day 1 for histological confirmation at Baseline. The biopsy(ies) must remove less than 25 percent of the area of the nBCC.
6. Target BCC must, in the assessment of the Investigator, be appropriate for FLD-103 intralesional treatment over the anticipated duration of the study.
7. Female volunteers, must:
   • Be of non-child-bearing potential i.e., surgically sterilised (hysterectomycomplete or partial removal of the uterus, bilateralaffecting both sides salpingectomyremoval of one (unilateral) or both (bilateral) fallopian tubes, bilateral oophorectomyremoval of one (unilateral) or both (bilateral) ovaries) at least 6 weeks before the Screening visit, or
   • Be postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and follicle-stimulating hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body (FSH) level and estradiol level consistent with postmenopausal status, per local laboratory guidelines).
8. Male volunteers, must:
   • Agree not to donate sperm from signing the consent form until at least 90 days after the last dosethe amount of medication taken of study drug.
   • If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
   • If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until at least 90 days after the last dose of study drug.