Prostate Cancers study: Dose expansion
Official title Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
ClinicalTrials.gov ID: NCT06926075
What this study is testing
What is KESONOTIDE™?
This is an investigational oral medicine being studied as a potential treatment for prostate cancer. It is designed to block a specific protein called vimentin, which may help stop cancer cells from growing or spreading.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to check if the drug is safe and to see how the body processes it.
- Who it's for
- People with advanced or metastatic solid tumors, such as prostate, breast, lung, ovarian, brain, pancreas, or skin cancer.
- What's involved
- Participants will receive the drug Kesonotide and undergo tests to monitor safety and how the drug moves through the body.
- Time commitment
- The study involves multiple visits over time, with the first part enrolling 20-32 people and the second part about 80 people.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Histologically or cytologically confirmed locally advanced/metastatic solid cancers.
You likely can't join if
- Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal...
- Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the...
- 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.
See the full eligibility 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.
- 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...
- 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.
- 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.
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Kogarah, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Miranda, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kogarah, New South Wales, Australia; Liverpool, New South Wales, Australia; Miranda, New South Wales, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.