LYT-100 in Healthy Volunteers and BCRL

STATUS

Recruiting
participants needed

82
sponsor

PureTech

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Updated on 19 February 2024

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cancer

breast cancer

metastasis

cancer surgery

carcinoma

reconstructive surgery

lymphedema

secondary lymphedema

nipple reconstruction

adjuvant

HER2

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 fasted conditions.

Part 3 is a trial of up to 6-months duration for safety, tolerability, PK, biomarkers and exploratory clinical assessments in breast carcinoma patients with secondary lymphoedema

Description

Part 1: This is a randomised, double-blind, placebo-controlled, multiple ascending dose design to assess the safety, tolerability and PK profile of multiple doses of LYT-100 administered under fed conditions at steady state in healthy participants. Up to 4 dosing cohorts are planned.

Part 2: The dose level immediately below the maximally tolerated dose in Part 1 will be used in Part 2. Following a minimum 7-day washout of the cohort that received this dose, subjects in Part 2 will be administered a single dose of their assigned treatment under fasting conditions to permit a comparison of the rate and extent of absorption of LYT-100 under fasting conditions to the equivalent dose in a prior fed cohort.

Part 3: Once the optimal dose and regimen is determined with or without food, Part 3 will follow with an open-label, single treatment arm to assess the safety, tolerability, PK, biomarkers and effect on exploratory clinical endpoints of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.

Details

Condition	Lymphedema, Lymphedema, Breast Cancer Related Lymphoedema
Age	18years - 80years
Treatment	Matching placebo, LYT-100
Clinical Study Identifier	NCT04243837
Sponsor	PureTech
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Part 1 and 2: Healthy Volunteers
	Male or female between 18 and 75 years old (inclusive) at the time of screening
	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
	Female or male between 18 and 80 years old (inclusive) at the time of informed consent
	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
	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
	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
	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
	Documented evidence of Stage 1 or 2 lymphoedema
	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
Exclusion Criteria
	Part 1 and 2: Healthy Volunteers
	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
	Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to screening
	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)
	History or presence at screening or baseline of a condition associated with significant immunosuppression
	Part 3: Patients with BRCL
	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
	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
	Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotising fasciitis, or current open wounds or sores in the affected extremity
	Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 2 years, determined at screening
	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

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LYT-100 in Healthy Volunteers and BCRL