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Soft Tissue SarcomaPhase 2NCT05755113

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

A Phase 2 study testing Tigilanol Tiglate in people with Soft Tissue Sarcoma, run by QBiotics Group Limited at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Tigilanol Tiglate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
13 Apr 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Head of Human Clinical Operations contact

+61 (0) 738 708 933

enquiries@qbiotics.com

United States1 site, 1 recruiting

  • Memorial Sloan Kettering Cancer Centre

    New York, New York, 10065

    Edmund Bartlett

    Recruiting

Other trials in United States

About this study

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.

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.

Read the detailed description

Primary Objective

  1. To evaluate tumour ablation in tumours and/or tumour segments following one or more treatments with tigilanol tiglate; and
  2. To evaluate the effect of tigilanol tiglate on overall disease control (not limited to injected tumours) (Stage 2 only).

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 +/- non-injected tumours;
  2. To evaluate the degree of immune response elicited with intratumoural tigilanol tiglate;
  3. To evaluate local recurrence rate;
  4. To evaluate Progression Free Survival (PFS) (Stage 2 only); and
  5. To evaluate metabolites after a single intratumoural injection of tigilanol tiglate (Stage 2 only).
Being tested
Tigilanol Tiglate
Keywords
extremeties, body wall, advanced, metastatic
Medical subject headings
Sarcoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tigilanol TiglateDrug

    Also called EBC-46

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

Study groups in NCT05755113
Study groupRoleWhat they receive
Single Arm, Open LabelExperimentalSingle or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area [BSA]) per treatment.
Receives: Drug: Tigilanol Tiglate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. ORR as determined by RECIST

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

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

Secondary outcomes (2)

  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Total number of Adverse Events (AEs) and Serious Adverse Events (SAEs) and number of AEs and SAEs deemed related to tigilanol tiglate.

    Measured: 6 months

  2. Systemic Exposure

    Evaluation of how much tigilanol tiglate is circulating in the blood after a single injection.

    Measured: Up to 24 hours after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start13 Apr 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755113
Sponsor's protocol ID
QB46C-H07
Other IDs
U1111-1282-2967
Status last verified
Feb 2026
First submitted
16 Feb 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tigilanol Tiglate in people with Soft Tissue Sarcoma, run by QBiotics Group Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head of Human Clinical Operations (+61 (0) 738 708 933, enquiries@qbiotics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumour Response (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05755113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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