Recruiting
Study Details
Design, interventions, and primary outcomes
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About This Study
This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers. It is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II. Primary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. Secondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.
Design
Study type: Interventional
Phases: Phase1, Phase2
Allocation: Non Randomized
Intervention model: Sequential
Primary purpose: Treatment
Masking/blinding: None
Interventions / Regimen
- Drug: A novel hGIIA-Vimentin Inhibitor — Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.
- Drug: Dose expansion — Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
Primary Outcomes
- To evaluate the safety and tolerability (Incidence of SAEs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (Treatment emergent adverse effects) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (Incidence and nature of DLTs) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (Changes in vital signs/Heart Rate bpm) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (Clinical safety laboratory parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (ECG parameters) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (ECOG performance status) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
- To evaluate the safety and tolerability (Changes in vital signs/Blood Pressure) of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. (Cycle 1 (21 days))
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-11-07
Completion: 2027-10-26
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-11-07
Completion: 2027-10-26
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Filamon LTD
Contact Information
Study Contact:
Admir Huseincehajic
+61467451064
admir.huseincehajic@filamon.com
Graham Kelly
+61 429 854 390
graham.kelly@filamon.com
Tracy Liaw
+61295985022
liawt@ramsayhealth.com.au
St George Private Hospital
Interventions
- Drug: A novel hGIIA-Vimentin Inhibitor — Phase I, dose escalation includes 4 increasing doses, 10mg, 30mg, 60mg and 120mg.
- Drug: Dose expansion — Phase II will enrol participants in selected indication(s) and will be given one of the two recommended doses by the SMC.
Study Locations (3 sites)
St George Private Hospital, Kogarah, New South Wales 2217 Australia
South Western Sydney Local Health District, Liverpool, New South Wales 2170 Australia
Southside Cancer Centre, Miranda, New South Wales 2228 Australia
Eligibility Criteria
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.
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.