Can a Zinc-Based compound fight cancer?
NCT ID NCT06506643
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests an experimental drug called KLS-1, a form of zinc aspartate enriched with a specific zinc isotope, in adults with certain solid tumors (like melanoma, prostate, or pancreatic cancer) or chronic lymphocytic leukemia (CLL). The goal is to find the safest and most effective dose, understand how the drug behaves in the body, and see if it can shrink tumors or slow cancer growth. Participants receive KLS-1 through an IV every 21 days and are monitored for side effects and any signs of anti-tumor activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KLS-1, a solution of zinc aspartate enriched with the isotope zinc-64, given by intravenous infusion
- What this could lead to
- If KLS-1 proves safe and shows anti-tumor activity, it could become a new treatment option for certain advanced cancers and chronic lymphocytic leukemia.
- What could go wrong
- This is an early, small trial focused on safety and dosing, so it may not lead to an effective treatment. Potential side effects are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Phase I and Phase II - solid tumors cohorts 1. Adult (male or female) aged ≥18 years. 2. Signed informed consent prior to any study-specific procedures. 3. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures. 4. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of: Phase I - 0 or 1; Phase II - 0-2. 5. Have an estimated life expectancy of ≥12 weeks. 6. Have adequate organ function including: a. Hematologic: * ANC ≥1.5 x 109/L * Platelets ≥100 x 109/L * Hemoglobin ≥90 g/L b. Hepatic: * Albumin ≥30 g/L * Bilirubin ≤1.5 times upper limit of normal (ULN) * ALT and AST ≤2.5 x ULN. If the liver has tumor involvement, AST and ALT ≤5 x ULN are acceptable. c. Renal: * Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 d. Blood coagulation: * International Normalized Ratio (INR) or activated partial prothrombin time (aPTT) \<1.5 x ULN and \> 0.8 x LLN lower limit of normal (LLN). 7. Have discontinued all chemotherapy, investigational therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas). 8. Have discontinued biologic therapy and immunotherapy at least 21 days prior to study enrollment. 9. Patients who have had radiation therapy must be fully recovered in the opinion of the investigator prior to enrolling on study. 10. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, molecularly-targeted therapy, cancer-related hormonal therapy, and investigational therapy (≤Grade 1 or baseline), with the exception of alopecia or Grade 2 neuropathy. 11. Have received at least 1 but no more than 4 prior systemic therapies for CLL. 12. Patients who have had surgery must be fully recovered in the opinion of the investigator prior to enrolling on study (but not less than 28 days for major surgery and 14 days for minor surgery). 13. Female patients with reproductive potential must agree to use 2 forms of highly effective contraception during the study and for at least 3 months following the last dose of IMP. Sexually active male patients must use a barrier method of contraception (condom) during the study and for at least 3 months following the last dose of IMP. 14. Females with child-bearing potential must have had a negative pregnancy test result ≤28 days prior to the first dose of IMP, as well as ≤1 day prior to the first dose of IMP. 15. Patients must be, in the judgment of the investigator, appropriate candidates for experimental therapy, and no standard therapy would confer clinical benefit to the patients. 16. Patients must have at least one lesion that is measurable by RECIST v.1.1. Phase I 17. Patients must have histologically proven evidence of any type of metastatic solid tumor (excluding primary brain tumor) that is evaluable and for whom no approved therapy with demonstrated clinical benefit is available or patients who are intolerant or have declined standard therapy. Phase II 18. Patients must have histologically proven evidence of a solid tumor that is locally advanced and/or metastatic and for whom no approved therapy with demonstrated clinical benefit is available or patients who are intolerant or have declined standard therapy as follows: 1. Cutaneous melanoma 2. Prostate cancer 3. Pancreatic cancer Phase II - CLL cohort 1. Adult (male or female) aged ≥18 years. 2. Signed informed consent prior to any study-specific procedures. 3. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures. 4. Subjects with confirmed diagnosis of per iwCLL 2008. 5. Documented disease progression that meets at least one of the iwCLL criteria for requiring treatment. 6. Measurable disease defined by either absolute lymphocyte count (ALC ≥ 5 x 109/L) or nodal lesion by computed tomography (CT). 7. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale ≤ 2. 8. Have an estimated life expectancy of ≥16 weeks. 9. Have adequate organ function including: a. Adequate hematologic function in the absence of transfusions (within 6 weeks prior to first dose of study medication) and independent of growth factor support for at least 7 days with the exception of pegylated G-CSF which requires at least 14 days, defined as: * WBC ≥3.0 x 109/L * ANC ≥1.0 x 109/L * Platelets ≥50 x 109/L or ≥ 25 × 109/L if thrombocytopenia is related to CLL b. Hepatic: * Albumin ≥30 g/L * Bilirubin ≤2 x ULN. Subjects with known Gilbert's Syndrome or disease-related hemolysis must have a total bilirubin ≤ 3 x ULN * ALT and AST ≤2.5 x ULN. c. Renal: * Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 d. Blood coagulation: * International Normalized Ratio (INR) or activated partial prothrombin time (aPTT) \<1.5 x ULN and \> 0.8 x LLN. 10. Have discontinued all chemotherapy, immunotherapy, investigational therapy, biologic therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas). 11. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic therapy, immunotherapy, molecularly targeted therapy, cancer-related hormonal therapy, and investigational therapy (≤Grade 1 or baseline), with the exception of alopecia or Grade 2 neuropathy. 12. The subject must also agree to pretreatment and on-treatment bone marrow aspirates. 13. Have received at least 1, but not more than 3 prior lines of therapy according to current guidelines. 14. Patients who have had surgery must be fully recovered in the opinion of the investigator prior to enrolling on study (but not less than 28 days for major surgery and 14 days for minor surgery). 15. Female patients with reproductive potential must agree to use 2 forms of highly effective contraception during the study and for at least 3 months following the last dose of IMP. Sexually active male patients must use a barrier method of contraception (condom) during the study and for at least 3 months following the last dose of IMP. 16. Females with child-bearing potential must have had a negative pregnancy test result ≤28 days prior to the first dose of IMP, as well as ≤1 day prior to the first dose of IMP. 17. Patients must be, in the judgment of the investigator, appropriate candidates for experimental therapy, and no standard therapy would confer clinical benefit to the patients. Exclusion Criteria: 1. Have another tumor of another location except basal cell carcinoma. 2. Have a history of organ transplant (e.g., heart, lungs, liver, bone marrow, or kidney). 3. Females who are pregnant or breastfeeding. 4. Have symptomatic human immunodeficiency virus (HIV) infection, known HIV positive test results or have chronic active hepatitis B or C (screening is not required). 5. Positive COVID-19 test or signs of coronavirus infections. 6. Have clinically significant cardiac disease including any of the following: * A history of congenital long QT syndrome, symptomatic bradycardia, ventricular arrhythmia, uncontrolled atrial fibrillation, second- or third-degree heart block, or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study. * Congestive heart failure (New York Heart Association Class ≥3). * Unstable angina pectoris, acute myocardial infarction, or stroke ≤12 months prior to enrollment. * QTcF prolongation \>450 msec. 7. Currently taking medication known to prolong the QT interval or induce TdP, which cannot be discontinued or substituted. 8. Uncontrolled type 1 or 2 diabetes with high risk of hypoglycemia. 9. Are a family member of the investigator or staff of the study site. 10. Are currently enrolled in another interventional clinical study of an investigational therapy. 11. Hypersensitivity to any components of KLS-1. Additional exclusion criterion for patients enrolled in Phase II to CLL cohort 12. History of Richter's transformation or prolymphocytic leukemia.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Medical Centre of Arensia Exploratory Medicine LLC
RECRUITINGKyiv, 01135, Ukraine
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Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus"
RECRUITINGKropyvnytskyi, 25006, Ukraine
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