Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

Recruiting now · Phase 1/Phase 2

Conditions studied: CLL, Solid Tumor, Adult

In brief

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.

Key facts

Study ID: NCT06506643
Run by: Vector Vitale LLC
People needed: 36
Starts: 2024-05-15
Expected to finish: 2029-12-31
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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.
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) <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.

You may not qualify 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 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 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.

Where it is running

Medical and Diagnostic Center of Private Enterprise of Private Manufacturing Company "Acinus" — Kropyvnytskyi, Ukraine (enrolling)
Medical Centre of Arensia Exploratory Medicine LLC — Kyiv, Ukraine (enrolling)

Full record on ClinicalTrials.gov

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