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Trial Title:
A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
NCT ID:
NCT05755113
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
extremeties
body wall
advanced
metastatic
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Open label, single arm
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tigilanol Tiglate
Description:
Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for
intratumoural treatment of a wide range of solid tumours.
Arm group label:
Single Arm, Open Label
Other name:
EBC-46
Summary:
A Phase IIa open label study evaluating the preliminary efficacy of intratumoural
tigilanol tiglate in advanced and/or metastatic soft tissue sarcoma of the extremities
and body wall.
Detailed description:
Primary Objective
1. To evaluate tumour ablation in tumours and/or tumour segments following one or more
treatments with tigilanol tiglate.
Secondary Objective
1. To assess the safety and tolerability of intratumoural injections with tigilanol
tiglate; and
2. To evaluate systemic exposure through pharmacokinetic (PK) assessment after a single
intratumoural injection of tigilanol tiglate.
Exploratory Objectives
1. To evaluate the microenvironment of injected tumours;
2. To evaluate the degree of immune response elicited with intratumoural tigilanol
tiglate;
3. To evaluate local recurrence rate.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Are willing and able to provide written informed consent for the study prior to any
protocol-specific procedures and to comply with all local and study requirements.
2. Are ≥ 18 years of age on the day of providing informed consent.
3. Have advanced and/or metastatic disease of the body wall or extremities that is
amenable to intratumoural injection either by palpation or under ultrasound guided
injection, that has been histologically or pathologically confirmed as an STS. STS
located on the scalp may also be considered for treatment.
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
5. Have life expectancy of more than 12 weeks.
6. Have adequate renal and hepatic function as assessed by the Investigator.
7. Female participants who are Women Of Child-Bearing Potential (WOCBP) must have a
negative serum pregnancy test at Screening (within 14 days of the first study drug
administration), must be willing to use a highly effective contraception from date
of consent, throughout the study period and up to 30 days after the last study drug
administration, and must not be breastfeeding.
8. Male participants with a potentially fertile female partner are eligible if they
have had a vasectomy or are willing to use adequate contraception from prior to
commencement of study drug administration, throughout the study period and up to 30
days after the last study drug administration, and must not donate sperm throughout
the study period and up to 30 days after the last study drug administration.
Exclusion Criteria:
1. Are planning to receive intratumoural treatment or radiotherapy to any of the
tumours intended for injection within 28 days prior to Screening, or during
treatment with tigilanol tiglate.
2. Have a tumour intended for injection that is immediately adjacent to, or with
infiltration into, any major artery or vein (e.g., if the tumour for injection is
located adjacent to the jugular vein).
3. Are receiving or have received other investigational agents or have used an
investigational device without undergoing a 28-day (or 5 half-lives, whichever is
shorter) wash-out period prior to their first treatment with tigilanol tiglate.
These patients must have recovered from all AEs due to previous investigational
therapies to ≤ Grade 1 at baseline.
4. Are receiving or have received systemic anticancer therapy, without undergoing a
28-day (or 5 half-lives, whichever is shorter) wash-out period prior to their first
treatment with tigilanol tiglate. These patients must have recovered from all AEs
due to previous therapies to ≤ Grade 1 at baseline. Patients with ≤ Grade 2
neuropathy may be eligible following discussion with Sponsor Medical Monitor.
5. Have had major surgery within 28 days of their first treatment with tigilanol
tiglate or anticipate the need for major surgery during the study period. Minor
surgical procedures are permitted, but with sufficient time for wound healing.
6. Have known, active brain metastases and/or carcinomatous meningitis. Participants
who have previously treated brain metastases and are neurologically stable can be
included.
7. Have any bleeding diathesis or coagulopathy that would make intratumoural injection
or biopsy unsafe, or if they are on therapeutic warfarin therapy.
8. Have a history of allergic reactions or severe hypersensitivity (Grade ≥ 3)
attributed to tigilanol tiglate or compounds of similar chemical or biologic
composition to tigilanol tiglate, any of its excipients or other agents used in the
study.
9. In the opinion of the treating Investigator, they are not an appropriate candidate
for the study for any reason (e.g., they have known psychiatric or substance abuse
disorder that would interfere with their ability to cooperate with the requirements
of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Centre
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Edmund Bartlett
Email:
Principal Investigator
Start date:
April 13, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
QBiotics Group Limited
Agency class:
Industry
Source:
QBiotics Group Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755113
