Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05234437




Registration number
NCT05234437
Ethics application status
Date submitted
11/01/2022
Date registered
10/02/2022
Date last updated
19/04/2023

Titles & IDs
Public title
A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma
Scientific 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
Secondary ID [1] 0 0
U1111-1258-4085
Secondary ID [2] 0 0
QB46C-H04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tigilanol tiglate

Experimental: Single arm open label - Single or multiple Intratumoural treatment of tigilanol tiglate at 3.6mg/m2 given at a minimum of 28-day intervals.


Treatment: Drugs: tigilanol tiglate
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumour Responses
Timepoint [1] 0 0
36 months
Primary outcome [2] 0 0
Tumour Ablation
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Tumour Recurrence Rate
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Safety and Tolerability
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Wound Healing
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
36 months

Eligibility
Key inclusion criteria
- Participants will be eligible for study participation if they meet ALL the following
criteria:

1. 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).

2. Are = 18 years of age.

3. 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.

4. 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.

5. Are willing to undergo biopsy sampling of tumour(s).

6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of = 2.

7. Have life expectancy of more than 12 weeks.

8. Female participants of childbearing potential must have a negative serum ß-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.

9. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants will be excluded from study participation if they meet ANY of the
following criteria:

1. 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.

2. 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).

3. Have a tumour intended for treatment located in an area where post-injection
swelling could compromise the airway.

4. 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).

5. Have a histologically confirmed diagnosis of uveal melanoma as the only intended
target tumour.

6. 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).

7. 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).

8. Have known, current or history of central nervous system metastases, active
cerebral metastasis and/or carcinomatous meningitis.

9. Have any bleeding diathesis or coagulopathy that would make intratumoural
injection or biopsy unsafe.

10. 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.

11. 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.

12. Have a known psychiatric or substance abuse disorder that would interfere with
the participant's ability to cooperate with the requirements of the study.

13. In the opinion of the treating Investigator, the participant is an inappropriate
candidate for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/07/2022
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Wollstonecraft
Recruitment hospital [2] 0 0
Cairns and Hinterland Hospital and Health Service - Cairns
Recruitment hospital [3] 0 0
Metro South Hospital and Health Service via Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
QBiotics Group Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05234437
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A/Prof. Robyn Saw, MBBS FRACS MS
Address 0 0
Melanoma Institute Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05234437