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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06926075




Registration number
NCT06926075
Ethics application status
Date submitted
20/03/2025
Date registered
13/04/2025

Titles & IDs
Public title
Early Phase Study of Kesonotide in Participants With Solid Tumours
Scientific title
An Adaptive Phase I/II Study of Kesonotide, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours
Secondary ID [1] 0 0
FLM-CT002
Universal Trial Number (UTN)
Trial acronym
ADVICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancers 0 0
Breast Cancer 0 0
Lung Cancers 0 0
Ovarian Cancer 0 0
Glioblastoma Multiforme (GBM) 0 0
Pancreas Cancer 0 0
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - A novel hGIIA-Vimentin Inhibitor
Treatment: Drugs - Dose expansion

Experimental: Phase I, Single Arm, dose escalation -

Experimental: 2 Arms of selected indication and recommended dose -


Treatment: Drugs: A novel hGIIA-Vimentin Inhibitor
Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.

Treatment: Drugs: Dose expansion
Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [1] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [1] 0 0
Cycle 1 (21 days)
Primary outcome [2] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [2] 0 0
Treatment emergent adverse effects (TEAEs)
Timepoint [2] 0 0
Cycle 1 (21 days)
Primary outcome [3] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [3] 0 0
Incidence and nature of dose-limiting toxicities (DLTs).
Timepoint [3] 0 0
Cycle 1 (21 days)
Primary outcome [4] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [4] 0 0
Changes in vital sign measurements (Hear rate in beats per minute, blood pressure in systolic and diastolic mm Hg)
Timepoint [4] 0 0
Cycle 1 (21 days)
Primary outcome [5] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [5] 0 0
Clinical safety laboratory parameters (abnormal haematology, clinical chemistry and coagulation blood tests; pregnancy test, as per CTCAE v5.0 classification
Timepoint [5] 0 0
Cycle 1 (21 days)
Primary outcome [6] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [6] 0 0
Electrocardiogram (ECG) parameters (Heart Rate, PR Interval, P wave, QRS Complex, T wave, ST Segment, QT Interval)
Timepoint [6] 0 0
Cycle 1 (21 days)
Primary outcome [7] 0 0
To evaluate the safety and tolerability of kesonotide as a monotherapy in participants with advanced/metastatic solid cancers.
Assessment method [7] 0 0
Eastern Cooperative Oncology Group (ECOG) performance status findings.
Timepoint [7] 0 0
Cycle 1 (21 days)

Eligibility
Key inclusion criteria
* Male or female adults (defined as = 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
* Has an ECOG performance status score of 0 or 1.
* Has a life expectancy of > 12 weeks in the opinion of the investigator.
* Measurable or evaluable disease by CT/MRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.
* Histologically or cytologically confirmed locally advanced/metastatic solid cancers.
* Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:
* Laboratory Value
* Hematology
* Platelet count > 100 x 109/L
* Hb > 9.0 g/dL
* ANC > 1.5 x 109/L
* Renal Function
* Creatinine < 1.5 x ULN
* Hepatic Function
* AST and ALT < 3 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
* Total bilirubin = 1.5 x ULN
* Serum albumin = 2.5 g/dL
* INR/PT and APTT = 1.5 x ULN
* Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.
* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.
* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.
* Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).

Additional Inclusion Criteria for Parts 2 and 3:

* Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).
* Defined diseases or disease states of interest, suitable for dose expansion.
* Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal anti-inflammatories, oral steroids at any dose; topical steroids and anti-inflammatories are allowable.
* Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 of the study period.
* Previous adverse reactions which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia and fatigue) at the screening visit.
* A clinically significant active infection determined by the investigator.
* Significant or recurrent third space accumulation (e.g., ascites or pleural effusions) according to the investigator.
* Has a medical history of myocardial infraction or unstable angina within 6 months before enrolment.
* Has a medical history of symptomatic CHF (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment.
* Has a history or presence of uncontrolled mental illness.
* The participant is expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements during the study.
* Participants are deemed inappropriate for this clinical trial at the discretion of the investigator.

Additional Exclusion Criteria for Parts 2 and 3:

- Patients must not have more than 2 prior lines of therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/10/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Filamon LTD
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Admir Huseincehajic
Address 0 0
Country 0 0
Phone 0 0
+61467451064
Email 0 0
admir.huseincehajic@filamon.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06926075