RECRUITING

A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma

Conditions

Soft Tissue Sarcoma extremeties body wall advanced metastatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2023-04-13

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05755113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Head of Human Clinical Operations

CONTACT

+61 (0) 738 708 933

enquiries@qbiotics.com

Principal Investigator

Edmund Bartlett, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Centre

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: QBiotics Group Limited

Edmund Bartlett, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13

Study Completion Date2025-03

Study Record Updates

Study Start Date2023-04-13

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

extremeties
body wall
advanced
metastatic

Additional Relevant MeSH Terms

Soft Tissue Sarcoma