Recruiting PHASE1, PHASE2 CLL

Tests treatment safety and results for CLL

Official title Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

ClinicalTrials.gov ID: NCT06506643

What this study is testing

What is Zinc-64 Aspartate?

Zinc-64 Aspartate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cll.

Also referred to as KLS-1.

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 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?

Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.

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

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.

You likely can't join if

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...
Positive COVID-19 test or signs of coronavirus infections.
Have clinically significant cardiac disease including any of the following:

See the full eligibility criteria

Who can 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.
Have an estimated life expectancy of ≥12 weeks.
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) \ 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...
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...
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...
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.
people 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: 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...
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. people 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) \ 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...
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...
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...
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.

What rules you out

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:
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...
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 treatment 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.

The study team makes the final eligibility decision.

Where it's taking place

Kyiv, Ukraine

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 - 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?

Study sites include Kyiv, Ukraine. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.