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MelanomaPhase 2NCT05234437

A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma

A Phase 2 study testing tigilanol tiglate in people with Melanoma, run by QBiotics Group Limited at 3 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A phase IIb, multicentre, open label study to evaluate the effectiveness, safety, and tolerability of intratumoural tigilanol tiglate in adult participants with Stage IIIB to IV M1c melanoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
tigilanol tiglate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
3 sitesAustralia
Study dates
9 Mar 2022to 18 Jul 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Participants will be eligible for study participation if they meet ALL the following criteria:
  • Are willing and able to provide written informed consent for the study prior to any protocol-required procedures and to comply with all study requirements. (Note: If a participant is unable to provide written informed consent, a legally acceptable representative may provide consent on their behalf).
  • Are ≥ 18 years of age.
  • Have a histologically confirmed diagnosis of melanoma that is Stage IIIB to IV M1c (AJCC 8th Ed.). These will be participants who are naïve to systemic therapy (i.e., not suitable for or have refused immunotherapy or targeted therapy), as well as participants who have progressed on a prior line of systemic therapy.
  • Have measurable disease per RECIST v1.1 including cutaneous, subcutaneous, or nodal tumours consisting of ≥ 1 target tumours accessible and amenable to intratumoural injection that can be accurately measured by contrast enhanced CT as assessed by the Investigator's local site radiology.
  • Are willing to undergo biopsy sampling of tumour(s).
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  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Have life expectancy of more than 12 weeks.
  • Female participants of childbearing potential must have a negative serum β-HCG pregnancy test at Screening (within 14 days prior to commencement of study drug administration), must be willing to use adequate highly effective contraception 28 days prior to commencement of study drug administration and throughout the study up to 30 days after the last study drug administration, and must not be breastfeeding.
  • Male participants with a potentially fertile partner are eligible if they have had a vasectomy or are willing to use adequate contraception and agree not donate sperm from commencement of study drug administration and throughout the study up to 30 days after the last study drug administration.

Who cannot join

  • Participants will be excluded from study participation if they meet ANY of the following criteria:
  • Are planning to receive intratumoural treatment or radiotherapy to any of the intended tumours for injection, or systemic therapy within 4 weeks prior to Screening, or during treatment with tigilanol tiglate.
  • Have a tumour intended for treatment 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).
  • Have a tumour intended for treatment located in an area where post-injection swelling could compromise the airway.
  • Have had any previous intervention in the area of the intended tumour in proximity of the airway (e.g., radiation therapy to the area such that tracking of the injected fluid may be unpredictable and could lead to airway swelling).
  • Have a histologically confirmed diagnosis of uveal melanoma as the only intended target tumour.
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  • Female participants that have a positive urine pregnancy test within 72 hours prior to the administration of study treatment(s) are not permitted to receive treatment (Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required).
  • Participants who have received other investigational agents, have participated in a study of an investigational agent or have used an investigational device must undergo a 4-week wash-out period prior to Screening. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks after the last dose of the previous investigational agent. They must have recovered from all AEs due to previous therapies to ≤ Grade 1 at baseline visit, except participants who have experienced endocrine immune-related AEs. (Note: If a participant received major surgery, they must have recovered adequately from the morbidity and/or complications from the intervention prior to starting study treatment).
  • Have known, current or history of central nervous system metastases, active cerebral metastasis and/or carcinomatous meningitis.
  • Have any bleeding diathesis or coagulopathy that would make intratumoural injection or biopsy unsafe.
  • Have significant peripheral vascular disease (e.g., participants who have claudication at rest) with accessible tumours intended for injection that are located in their extremities.
  • 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 or any of its excipients or other agents used in the study.
  • Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • In the opinion of the treating Investigator, the participant is an inappropriate candidate for the study.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Cairns and Hinterland Hospital and Health Service

    Cairns, Queensland, 4870

  • Melanoma Institute Australia

    Wollstonecraft, New South Wales, 2065

  • Metro South Hospital and Health Service via Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: A Phase IIb, Multicentre, Open Label Study to Evaluate the Effectiveness, Safety and Tolerability of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma

A phase IIb, multicentre, open label study to evaluate the effectiveness, safety, and tolerability of intratumoural tigilanol tiglate in adult participants with Stage IIIB to IV M1c melanoma

Read the detailed description

Primary Objective

  1. To evaluate the tumour responses of both injected and non injected tumours following treatment with intratumoural injections of tigilanol tiglate into one or more tumours (according to RECIST v1.1); and
  2. To assess the tumour ablation rate following treatments with intratumoural injections of tigilanol tiglate.

Secondary Objectives

  1. To assess the tumour recurrence rate at injected tumour site(s);
  2. To assess the safety and tolerability of intratumoural injections of tigilanol tiglate;
  3. To assess the degree of wound healing at injection sites; and
  4. To evaluate disease control by looking at Progression Free Survival (PFS) in melanoma participants receiving tigilanol tiglate injections over 36 months.

Exploratory Objectives

  1. To evaluate Overall Survival (OS) in melanoma participants receiving tigilanol tiglate injections over 36 months;
  2. To assess the tumour microenvironment by looking at the degree of immune cell infiltration in non-injected tumours; and
  3. To assess the Quality of Life (QoL) in melanoma participants receiving tigilanol tiglate injections.
Conditions
Melanoma
Being tested
tigilanol tiglate
Keywords
Melanoma, Intratumoural, Epoxytigilane, Tigilanol Tiglate
Medical subject headings
Melanoma

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

    Single or multiple Intratumoural treatments of tigilanol tiglate up to a fixed dose level of 3.6mg/m2.

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

Study groups in NCT05234437
Study groupRoleWhat they receive
Single arm open labelExperimentalSingle or multiple Intratumoural treatment of tigilanol tiglate at 3.6mg/m2 given at a minimum of 28-day intervals.
Receives: Drug: tigilanol tiglate

What is being measured

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

  1. Tumour Responses

    • To evaluate the tumour responses of both injected and non injected tumours following treatment with intratumoural injections of tigilanol tiglate into one or more tumours (long term tumour response according to RECIST v1.1 criteria).

    Measured: 36 months

  2. Tumour Ablation

    • To assess the tumour ablation rate following treatment(s) with intratumoural injections of tigilanol tiglate.

    Measured: 36 months

Secondary outcomes (4)

  1. Tumour Recurrence Rate

    • To assess the tumour recurrence rate at injected tumour site(s)

    Measured: 36 months

  2. Safety and Tolerability

    Total number of Adverse Events and Serious Adverse Events. Number of Adverse Events and Serious Adverse Events deemed related to tigilanol tiglate.

    Measured: 36 months

  3. Wound Healing

    • To assess the degree of wound healing at injection site(s) using a specifically designed Injection Site Assessment Worksheet, observed at 14 and 28 days post treatment.

    Measured: 28 days

  4. Progression Free Survival (PFS)

    • To evaluate disease control by looking at Progression Free Survival (PFS) in melanoma participants receiving tigilanol tiglate injections over 36 months

    Measured: 36 months

Timeline

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

  1. First posted10 Feb 2022
  2. Study start9 Mar 2022
  3. Primary completion18 Jul 2022
  4. Study completion18 Jul 2022

Why it stopped: Insufficient Patient Recruitment Rates

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 multicentre study
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234437
Sponsor's protocol ID
QB46C-H04
Other IDs
U1111-1258-4085
Status last verified
Oct 2022
First submitted
11 Jan 2022
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tigilanol tiglate in people with Melanoma, run by QBiotics Group Limited at 3 sites in Australia.

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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. 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?

The study was stopped early (reason given: Insufficient Patient Recruitment Rates). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumour Responses (time frame: 36 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 NCT05234437.

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 19 Apr 2023.

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