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

NCT05755113 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: QB46C-H07U1111-1282-2967
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma

Keywords

extremeties; body wall; advanced; metastatic

Outcome Measures

Primary Outcomes (2)

• Tumour Response

  Proportion of participants who have achieved partial or complete ablation of treated tumour(s) and/or tumour segment(s) following injection(s) with tigilanol tiglate.

  6 months

• ORR as determined by RECIST

  Objective Response Rate (ORR) as Determined by Response Evaluation Criteria in Solid Tumours (RECIST) V1.1

  3 and 6 months post initial treatment (Stage 2 only)

Secondary Outcomes (2)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  6 months

• Systemic Exposure

  Up to 24 hours after the first dose

Other Outcomes (5)

• Tumour Microenvironment

  7 days before and between 28 and 56 days after standard of care (Stage 2).

• Evaluation of Peripheral Blood Mononucleocytes (PBMCs)

  14 days after first treatment; as well as 7 days before and 14, 28 and 56 days after (only for participants who commence a systemic anti-cancer treatment after treatment)

• Local Recurrence Rate at injection site(s)

  6 months

Study Arms (1)

Single Arm, Open Label

EXPERIMENTAL

Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.

Drug: Tigilanol Tiglate

Interventions

Tigilanol Tiglate DRUG

Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.

Also known as: EBC-46

Single Arm, Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Are ≥ 18 years of age on the day of providing informed consent.
• 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.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Have life expectancy of more than 12 weeks.
• Have adequate renal and hepatic function as assessed by the Investigator.
• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• 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.
• 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.
• 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.
• Have known, active brain metastases and/or carcinomatous meningitis. Participants who have previously treated brain metastases and are neurologically stable can be included.
• Have any bleeding diathesis or coagulopathy that would make intratumoural injection or biopsy unsafe, or if they are on therapeutic warfarin therapy.
• 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.
• 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.

Sponsors & Collaborators

• QBiotics Group Limited: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Centre

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Interventions

EBC-46

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edmund Bartlett, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Head of Human Clinical Operations

CONTACT

+61 (0) 738 708 933; enquiries@qbiotics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm. Stage 1 - 10 evaluable participants, max of 5 treatments, 28 days apart. Stage 2 - up to 40 evaluable participants with a maximum of 10 participants in each of four histologically different groups: (i) angiosarcoma, (ii) leiomyosarcoma, (iii) myxofibrosarcoma, and (iv) other mixed origin sarcomas, max of 3 treatments, 7 days apart.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 6, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)