Overview

LYT-100 in Healthy Volunteers and BCRL

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Part 1 is a multiple ascending dose trial in healthy volunteers (HV) of LYT-100 to determine safety, tolerability, and pharmacokinetic (PK) profile under fed conditions. Part 2 is a single dose safety, tolerability, and PK trial in HV of LYT-100 under fed and fasted conditions. Part 3 is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
PureTech
Collaborator:
Novotech (Australia) Pty Limited
Criteria
Main Inclusion Criteria:

Part 1 and 2: Healthy Volunteers

1. Male or female between 18 and 75 years old (inclusive) at the time of screening.

2. In good general health at screening, free from clinically significant unstable
medical, surgical or psychiatric illness, at the discretion of the Investigator.

Part 3: Patients with BRCL

1. Female or male between 18 and 80 years old (inclusive) at the time of informed
consent.

2. At least 6 months since any type of breast cancer surgery (excluding fine needle
aspiration biopsy [FNA]), at the time of study screening. No intention to have breast
reconstructive surgery, nipple reconstruction and/or tattooing during the course of
the study.

3. At least 3 months since completion of all types of treatment for breast cancer,
including but not limited to neoadjuvant, radiotherapy, chemotherapy and
immunotherapy, at the time of study screening.

4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2
therapy at the time of screening, with no planned changes to this therapy throughout
the duration of the study.

5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast
cancer and/or metastasis for at least 6 months since breast cancer surgery, as
determined at screening and baseline.

6. Documented evidence of Stage 1 or 2 lymphedema.

7. Receiving standard of care compression or agreeable to using care compression, or no
compression at all ≥ 4 weeks prior to screening and throughout the study.

Main Exclusion Criteria:

Part 1 and 2: Healthy Volunteers

1. History or presence of malignancy at screening or baseline, with the exception of
adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or
carcinoma in-situ of the cervix.

2. Clinically significant infection within 28 days of the start of dosing, or infections
requiring parenteral antibiotics within the 6 months prior to screening.

3. Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs within 3 months prior to study drug
administration; corticosteroids are permitted at the discretion of the Investigator).

4. History or presence at screening or baseline of a condition associated with
significant immunosuppression

Part 3: Patients with BRCL

1. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e.,
sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or
lymphatic or vascular malformation, determined at screening.

2. Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs within 3 months prior to study drug
administration; corticosteroids are permitted at the discretion of the PI.

3. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis,
dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected
extremity.

4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema
greater than 4 years, determined at screening.

5. Initiated use of compression or manual lymphatic drainage or other lymphoedema
therapies at the start of the study within 4 weeks of the screening visit. Rescreening
is allowed following a course of stable compression regimen of > 4 weeks.