CLLPhase 1/2NCT06506643
Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
A Phase 1/2 study testing Zinc-64 Aspartate in people with CLL and Solid Tumor, Adult, run by Vector Vitale LLC at 2 sites in Ukraine.
Trial summary
The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL, Solid Tumor, Adult
- What is being tested?
- Zinc-64 Aspartate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUkraine
- Study dates
- 15 May 2024to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I and Phase II - solid tumors cohorts
- Adult (male or female) aged ≥18 years.
- Signed informed consent prior to any study-specific procedures.
- Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of:
- Phase I - 0 or 1; Phase II - 0-2.
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- Have an estimated life expectancy of ≥12 weeks.
- Have adequate organ function including:
- 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.
- 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).
- 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).
- Have discontinued biologic therapy and immunotherapy at least 21 days prior to study enrollment.
- Patients who have had radiation therapy must be fully recovered in the opinion of the investigator prior to enrolling on study.
- 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.
- Have received at least 1 but no more than 4 prior systemic therapies for CLL.
- 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).
- 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.
- 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.
- 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.
- 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:
- Cutaneous melanoma
- Prostate cancer
- Pancreatic cancer
- Phase II - CLL cohort
- Adult (male or female) aged ≥18 years.
- Signed informed consent prior to any study-specific procedures.
- Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Subjects with confirmed diagnosis of per iwCLL 2008.
- Documented disease progression that meets at least one of the iwCLL criteria for requiring treatment.
- Measurable disease defined by either absolute lymphocyte count (ALC ≥ 5 x 109/L) or nodal lesion by computed tomography (CT).
- Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale ≤ 2.
- Have an estimated life expectancy of ≥16 weeks.
- Have adequate organ function including:
- 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.
- 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).
- 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.
- The subject must also agree to pretreatment and on-treatment bone marrow aspirates.
- Have received at least 1, but not more than 3 prior lines of therapy according to current guidelines.
- 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).
- 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.
- 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.
- 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.
Who cannot join
- Have another tumor of another location except basal cell carcinoma.
- Have a history of organ transplant (e.g., heart, lungs, liver, bone marrow, or kidney).
- Females who are pregnant or breastfeeding.
- Have symptomatic human immunodeficiency virus (HIV) infection, known HIV positive test results or have chronic active hepatitis B or C (screening is not required).
- Positive COVID-19 test or signs of coronavirus infections.
- Have clinically significant cardiac disease including any of the following:
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- 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.
- Currently taking medication known to prolong the QT interval or induce TdP, which cannot be discontinued or substituted.
- Uncontrolled type 1 or 2 diabetes with high risk of hypoglycemia.
- Are a family member of the investigator or staff of the study site.
- Are currently enrolled in another interventional clinical study of an investigational therapy.
- Hypersensitivity to any components of KLS-1. Additional exclusion criterion for patients enrolled in Phase II to CLL cohort
- History of Richter's transformation or prolymphocytic leukemia.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine2 sites, 2 recruiting
- Recruiting
Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus"
Kropyvnytskyi, 25006
Grygorii Ursol, MD, PhD
Andrew Makovetsskyi, MD, PhD, +380672355873, andriy.makovetskyy@cls-ukraine.com
- Recruiting
Medical Centre of Arensia Exploratory Medicine LLC
Kyiv, 01135
Prof. Valerii Cheshuk, MD, PhD
Andrew Makovetsskyi, MD, PhD, +380672355873, andriy.makovetskyy@cls-ukraine.com
About this study
Official title: A Phase I/II Open-label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of KLS-1 as Monotherapy in Patients With Malignant Neoplasms
The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). The main questions it aims to answer are:
- To define Dose Limiting Toxicities (DLT) and maximum tolerated dose (MTD) of KLS-1
- To select the recommended Phase II Dose (P2D) of KLS-1
- To determine the single dose and multiple dose PK profile following IV administration of KLS-1
- What is the safest and most effective dose of KLS-1?
- Does KLS-1 show anti-tumor activity in patients?
- To evaluate preliminary efficacy of KLS-1 in up to 4 cohorts of locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer), or CLL.
- To evaluate 12-months progression-free survival (PFS) and duration of response (DOR) follow-up after the last dose of KLS-1
Read more
Participants will:
- Receive KLS-1 through intravenous (IV) infusions in 21-day cycles.
- Be monitored for side effects and improvements in their malignancy. Investigators will compare different doses of KLS-1 in the initial phase to find the best dose for Phase II. Once the P2D is defined, it will be tested in a larger group to see its effects on locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer) and CLL.
Read the detailed description
This is a Phase I/II, open-label, non-randomized, multicenter study of KLS-1 administered via intravenous (IV) infusions in 21-day treatment cycles to adult participants with different types of solid tumors and CLL.
Phase I (a dose-escalation part) will explore multiple-dose levels, PK and select a single dose level to explore in Phase II of the study. A conventional 3+3 design will be utilized. Once a dose level is selected, the additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose (P2D). Phase II (a dose expansion part) will evaluate the evidence of anti-tumor activity of the selected dose in four dose expansion cohorts of patients with different types of solid locally advanced and/or metastatic tumors or CLL. The study is designed to identify and characterize the safety, tolerability, efficacy, and PK profile of KLS-1 in oncological patients.
- Conditions
- CLL, Solid Tumor, Adult
- Being tested
- Zinc-64 Aspartate
- Keywords
- malignant melanoma, prostate cancer, pancreatic cancer, CLL, chronic lymphocytic leukemia, Zn, Zinc, KLS-1, Malignant Neoplasms, Neoplasms, Metastatic Tumors, Zinc Aspartate
- Medical subject headings
- Melanoma, Prostatic Neoplasms, Pancreatic Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc-64 AspartateDrug
Also called KLS-1
KLS-1 drug substance is Zinc Aspartate enriched with isotope Zinc-64 to 99.2% mass fraction of total Zinc. KLS-1 investigational medicinal product (IMP) is formulated as a solution, containing 25.64 mg of drug substance in 1 ml and inactive ingredients (water for injections, USP, EuPh).
| Study group | Role | What they receive |
|---|---|---|
| KLS-1 dose escalation Phase I - Cohort 1: 2.0 mg/kg | Experimental | 3-6 patients will receive KLS-1 at 2.0 mg/kg. Receives: Drug: Zinc-64 Aspartate |
| KLS-1 dose escalation Phase I - Cohort 2: 3.0 mg/kg | Experimental | 3-6 patients will receive KLS-1 at 3.0 mg/kg. Receives: Drug: Zinc-64 Aspartate |
| KLS-1 dose escalation Phase I - Cohort 3: 3.9 mg/kg | Experimental | 3-6 patients will receive KLS-1 at 3.9 mg/kg. Receives: Drug: Zinc-64 Aspartate |
| KLS-1 dose escalation Phase I - Cohort 4: 4.75 mg/kg | Experimental | 3-6 patients will receive KLS-1 at 4.75 mg/kg. Receives: Drug: Zinc-64 Aspartate |
| KLS-1 dose escalation Phase I - Cohort 5: 6.5 mg/kg | Experimental | 3-6 patients will receive KLS-1 at 6.5 mg/kg. Receives: Drug: Zinc-64 Aspartate |
| KLS-1 dose expansion Phase II cohort | Experimental | The Phase II dose (P2D) defined in Phase I will be administered in a dose expansion cohort during 5 weeks of continuous bi-weekly administration of KLS-1, demonstrating that this dose was well-tolerated and safe. Receives: Drug: Zinc-64 Aspartate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs)
Dose Limiting Toxicities (DLTs) at Dose Escalation Cohorts
Measured: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Number of participants with Dose Limiting Toxicities (DLTs)
Dose Limiting Toxicities (DLTs) at Dose Confirmation Cohorts
Measured: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 6, Cycle 2 Day 12, Cycle 2 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Number of participants with Treatment Emergent Adverse Events (AEs)
Adverse Events (AEs) as characterized by type, frequency, severity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, timing, seriousness and relationship to study therapy
Measured: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 6, Cycle 2 Day 12, Cycle 2 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Number of participants with Treatment Emergent Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs) as characterized by type, frequency, severity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, timing, seriousness and relationship to study therapy
Measured: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 6, Cycle 2 Day 12, Cycle 2 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Number of participants with Overall Response Rate (ORR)
ORR evaluated upon using RECIST, version 1.1 and the based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria per Investigator assessment
Measured: 30-Day Follow-up, Q 3-Months Follow-up, 12-Months Follow -up
Secondary outcomes (8)
Cmax of KLS-1
PK parameters: maximum plasma concentration (Cmax) of KLS-1
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
AUC0-t and AUC0-∞ of KLS-1
PK parameters: area under the plasma concentration-time curve (AUC0-t and AUC0-∞) of KLS-1
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
T1/2 of KLS-1
PK parameters: Half-Life (T1/2) of KLS-1
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Tmax of KLS-1
PK parameters: time to reach maximum plasma concentration (Tmax) of KLS-1
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
CL/F of KLS-1
PK parameters: clearance (CL/F) of KLS-1
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Vd/F of KLS-1
PK parameters: apparent volume of distribution (Vd/F) of KLS-1
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Ae(0-t) of Zinc
PK parameters: cumulative amount of Zinc excreted in urine (Ae(0-t))
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Rmax of Zinc
PK parameters: maximum ate of urinary excretion (Rmax) of Zinc
Measured: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start15 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase I (a dose-escalation part) will explore multiple dose levels, pharmacokinetics (PK), and select a single dose level to explore in Phase II of the study. A conventional 3+3 design will be utilized. Once a dose level is selected, an additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose (P2D).
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vector Vitale LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Valerii Cheshuk, MD, PhD, Principal investigator, Medical Centre of Arensia Exploratory Medicine LLCGrygorii Ursol, MD, PhD, Principal investigator, Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506643
- Sponsor's protocol ID
- VV022-02
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of KLS-1 as Monotherapy in Patients With Malignant Neoplasms
- ClinicalTrials.gov ID
- NCT06506643
- Acronym / sponsor ID
- VV022-02
- Conditions
- CLL, Solid Tumor, Adult
- Keywords
- malignant melanoma, prostate cancer, pancreatic cancer, CLL, chronic lymphocytic leukemia, Zn, Zinc, KLS-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Vector Vitale LLCIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). The main questions it aims to answer are:
- To define Dose Limiting Toxicities (DLT) and maximum tolerated dose (MTD) of KLS-1
- To select the recommended Phase II Dose (P2D) of KLS-1
- To determine the single dose and multiple dose PK profile following IV administration of KLS-1
- What is the safest and most effective dose of KLS-1?
- Does KLS-1 show anti-tumor activity in patients?
- To evaluate preliminary efficacy of KLS-1 in up to 4 cohorts of locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer), or CLL.
- To evaluate 12-months progression-free survival (PFS) and duration of response (DOR) follow-up after the last dose of KLS-1
Participants will:
- Receive KLS-1 through intravenous (IV) infusions in 21-day cycles.
- Be monitored for side effects and improvements in their malignancy. Investigators will compare different doses of KLS-1 in the initial phase to find the best dose for Phase II. Once the P2D is defined, it will be tested in a larger group to see its effects on locally advanced or metastatic solid tumor (malignant melanoma, prostate cancer, pancreatic cancer) and CLL.
Detailed description
This is a Phase I/II, open-label, non-randomized, multicenter study of KLS-1 administered via intravenous (IV) infusions in 21-day treatment cycles to adult participants with different types of solid tumors and CLL.
Phase I (a dose-escalation part) will explore multiple-dose levels, PK and select a single dose level to explore in Phase II of the study. A conventional 3+3 design will be utilized. Once a dose level is selected, the additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose (P2D). Phase II (a dose expansion part) will evaluate the evidence of anti-tumor activity of the selected dose in four dose expansion cohorts of patients with different types of solid locally advanced and/or metastatic tumors or CLL. The study is designed to identify and characterize the safety, tolerability, efficacy, and PK profile of KLS-1 in oncological patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Phase I (a dose-escalation part) will explore multiple dose levels, pharmacokinetics (PK), and select a single dose level to explore in Phase II of the study. A conventional 3+3 design will be utilized. Once a dose level is selected, an additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose (P2D).
| Arm | Type | Receives |
|---|---|---|
| KLS-1 dose escalation Phase I - Cohort 1: 2.0 mg/kg | Experimental | Drug: Zinc-64 Aspartate3-6 patients will receive KLS-1 at 2.0 mg/kg. |
| KLS-1 dose escalation Phase I - Cohort 2: 3.0 mg/kg | Experimental | Drug: Zinc-64 Aspartate3-6 patients will receive KLS-1 at 3.0 mg/kg. |
| KLS-1 dose escalation Phase I - Cohort 3: 3.9 mg/kg | Experimental | Drug: Zinc-64 Aspartate3-6 patients will receive KLS-1 at 3.9 mg/kg. |
| KLS-1 dose escalation Phase I - Cohort 4: 4.75 mg/kg | Experimental | Drug: Zinc-64 Aspartate3-6 patients will receive KLS-1 at 4.75 mg/kg. |
| KLS-1 dose escalation Phase I - Cohort 5: 6.5 mg/kg | Experimental | Drug: Zinc-64 Aspartate3-6 patients will receive KLS-1 at 6.5 mg/kg. |
| KLS-1 dose expansion Phase II cohort | Experimental | Drug: Zinc-64 AspartateThe Phase II dose (P2D) defined in Phase I will be administered in a dose expansion cohort during 5 weeks of continuous bi-weekly administration of KLS-1, demonstrating that this dose was well-tolerated and safe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (60 listed)
- Phase I and Phase II - solid tumors cohorts
- Adult (male or female) aged ≥18 years.
- Signed informed consent prior to any study-specific procedures.
- Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of:
Key exclusion criteria (16 listed)
- Have another tumor of another location except basal cell carcinoma.
- Have a history of organ transplant (e.g., heart, lungs, liver, bone marrow, or kidney).
- Females who are pregnant or breastfeeding.
- Have symptomatic human immunodeficiency virus (HIV) infection, known HIV positive test results or have chronic active hepatitis B or C (screening is not required).
- Positive COVID-19 test or signs of coronavirus infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc-64 AspartateAlso: KLS-1KLS-1 drug substance is Zinc Aspartate enriched with isotope Zinc-64 to 99.2% mass fraction of total Zinc. KLS-1 investigational medicinal product (IMP) is formulated as a solution, containing 25.64 mg of drug substance in 1 ml and inactive ingredients (water for injections, USP, EuPh). | Drug | KLS-1 dose escalation Phase I - Cohort 1: 2.0 mg/kg, KLS-1 dose escalation Phase I - Cohort 2: 3.0 mg/kg, KLS-1 dose escalation Phase I - Cohort 3: 3.9 mg/kg, KLS-1 dose escalation Phase I - Cohort 4: 4.75 mg/kg, KLS-1 dose escalation Phase I - Cohort 5: 6.5 mg/kg, KLS-1 dose expansion Phase II cohort |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Dose Limiting Toxicities (DLTs) at Dose Escalation Cohorts
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 6, Cycle 2 Day 12, Cycle 2 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Dose Limiting Toxicities (DLTs) at Dose Confirmation Cohorts
Number of participants with Treatment Emergent Adverse Events (AEs)
Time frame: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 6, Cycle 2 Day 12, Cycle 2 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Adverse Events (AEs) as characterized by type, frequency, severity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, timing, seriousness and relationship to study therapy
Number of participants with Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 6, Cycle 2 Day 12, Cycle 2 Day 21, 30-Day Follow-Up (Each cycle is 28 days)
Serious Adverse Events (SAEs) as characterized by type, frequency, severity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, timing, seriousness and relationship to study therapy
Number of participants with Overall Response Rate (ORR)
Time frame: 30-Day Follow-up, Q 3-Months Follow-up, 12-Months Follow -up
ORR evaluated upon using RECIST, version 1.1 and the based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria per Investigator assessment
8 secondary outcomes
Cmax of KLS-1
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
AUC0-t and AUC0-∞ of KLS-1
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
T1/2 of KLS-1
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Tmax of KLS-1
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
CL/F of KLS-1
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Vd/F of KLS-1
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Ae(0-t) of Zinc
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Rmax of Zinc
Time frame: Cycle 1 Day 1,Cycle 1 Day 3, Cycle 1 Day 9, Cycle 1 Day 21, Cycle 2 Day 1, Cycle 2 Day 3, Cycle 2 Day 21 (Each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Valerii Cheshuk, MD, PhD principal investigator
Medical Centre of Arensia Exploratory Medicine LLC
Grygorii Ursol, MD, PhD principal investigator
Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus"
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zinc-64 Aspartate in people with CLL and Solid Tumor, Adult, run by Vector Vitale LLC at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 60 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Max Temnik (+1 305 331-12 13, clinicaltrials@vectorvitale.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 Day 1, Cycle 1 Day 3, Cycle 1 Day 6, Cycle 1 Day 9, Cycle 1 Day 12, Cycle 1 Day 21, 30-Day Follow-Up (Each cycle is 28 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.