Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For the solid tumour groups (Phase I and Phase II):

• Adults aged 18 or older
• People who have signed a consent form before any study procedures begin
• People who are willing to be available and follow study procedures for the full duration of the trial
• People whose general physical functioning falls within the required range on a standard oncology fitness scale (Phase I: relatively well-functioning; Phase II: well-functioning to mildly limited — confirm with trial site)
• People with an estimated life expectancy of at least 12 weeks
• People whose blood, liver, kidney, and clotting results fall within the ranges required by the trial (confirm with trial site for specific values)
• People who stopped chemotherapy, investigational treatments, targeted therapy, or cancer-related hormone therapy at least 30 days before joining (or 6 weeks for certain specific drugs — confirm with trial site)
• People who stopped biological therapy and immunotherapy at least 21 days before joining
• People who have fully recovered from any previous radiation therapy, in the opinion of the treating doctor
• People who have mostly recovered from side effects of any prior cancer treatment (side effects must be mild or back to their usual baseline, except for hair loss or certain nerve-related side effects)
• People who have received at least 1 but no more than 4 prior systemic treatments for their cancer
• People who have fully recovered from any prior surgery — at least 28 days after major surgery or 14 days after minor surgery
• Women who are able to become pregnant and agree to use 2 highly effective forms of contraception during the study and for at least 3 months after the last dose; sexually active men who agree to use a condom during the study and for at least 3 months after the last dose
• Women who are able to become pregnant and have had a negative pregnancy test no more than 28 days before the first dose, and again no more than 1 day before the first dose
• People whom the treating doctor considers appropriate for experimental treatment, and for whom no standard treatment is expected to provide meaningful benefit
• People who have at least one tumour that can be measured using standard imaging guidelines

Additionally, for Phase I (all solid tumour types):

• People with a laboratory-confirmed advanced (metastatic) solid tumour of any type (primary brain tumours are not included), for whom no approved treatment with proven benefit is available, or who cannot tolerate or have chosen not to have standard treatment

Additionally, for Phase II (specific solid tumour types):

• People with a laboratory-confirmed locally advanced or metastatic solid tumour — specifically cutaneous melanoma, prostate cancer, or pancreatic cancer — for whom no approved treatment with proven benefit is available, or who cannot tolerate or have chosen not to have standard treatment

For the chronic lymphocytic leukaemia (CLL) group (Phase II):

• Adults aged 18 or older
• People who have signed a consent form before any study procedures begin
• People who are willing to be available and follow study procedures for the full duration of the trial
• People with a confirmed diagnosis of CLL according to established medical guidelines
• People whose CLL has been documented to have progressed and meets at least one standard medical criterion for needing treatment
• People with measurable disease, based on either blood count or scan results
• People whose general physical functioning falls within the required range on a standard oncology fitness scale (confirm with trial site)
• People with an estimated life expectancy of at least 16 weeks
• People whose blood, liver, kidney, and clotting results fall within the ranges required by the trial, without recent blood transfusions or certain blood-boosting medications (confirm with trial site for specific values and timeframes)
• People who stopped chemotherapy, immunotherapy, investigational treatments, biological therapy, targeted therapy, or cancer-related hormone therapy at least 30 days before joining (or 6 weeks for certain specific drugs — confirm with trial site)
• People who have mostly recovered from side effects of any prior cancer treatment (side effects must be mild or back to their usual baseline, except for hair loss or certain nerve-related side effects)
• People who agree to bone marrow sampling both before and during the study
• People who have received at least 1 but no more than 3 prior lines of treatment for their CLL
• People who have fully recovered from any prior surgery — at least 28 days after major surgery or 14 days after minor surgery
• Women who are able to become pregnant and agree to use 2 highly effective forms of contraception during the study and for at least 3 months after the last dose; sexually active men who agree to use a condom during the study and for at least 3 months after the last dose
• Women who are able to become pregnant and have had a negative pregnancy test no more than 28 days before the first dose, and again no more than 1 day before the first dose
• People whom the treating doctor considers appropriate for experimental treatment, and for whom no standard treatment is expected to provide meaningful benefit

Who may not be able to join:

• People who have another active cancer elsewhere in the body, except for a type of common skin cancer called basal cell carcinoma
• People who have had an organ transplant (such as heart, lung, liver, bone marrow, or kidney)
• Women who are pregnant or breastfeeding
• People with active or symptomatic HIV infection, a known positive HIV test result, or chronic active hepatitis B or C
• People who have tested positive for COVID-19 or have signs of a coronavirus infection
• People with significant heart conditions, including a history of certain inherited or acquired heart rhythm problems, heart failure of a certain severity, unstable chest pain, a heart attack or stroke within the past 12 months, or an abnormal heart electrical reading above a certain level (confirm with trial site)
• People who are currently taking medications known to affect heart rhythm in a specific way (called QT prolongation) and cannot stop or switch to a different medication
• People with poorly controlled type 1 or type 2 diabetes that carries a high risk of dangerously low blood sugar
• People who are a family member of the investigator or a staff member at the trial site
• People who are currently enrolled in another interventional clinical trial of an investigational treatment
• People with a known allergy or sensitivity to any component of the study drug (KLS-1)

Additionally, for the CLL group only:

• People with a history of a condition in which CLL has transformed into a more aggressive type of cancer (Richter's transformation) or a related blood cancer called prolymphocytic leukaemia

Important: Always verify eligibility with the trial site directly before applying.