OncoMatch/Clinical Trials/NCT06506643
Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
Is NCT06506643 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Zinc-64 Aspartate for cll.
Treatment: Zinc-64 Aspartate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Tumor Agnostic
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Solid tumor: ANC ≥1.5 x 10^9/L, Platelets ≥100 x 10^9/L, Hemoglobin ≥90 g/L; CLL: WBC ≥3.0 x 10^9/L, ANC ≥1.0 x 10^9/L, Platelets ≥50 x 10^9/L or ≥25 x 10^9/L if thrombocytopenia is related to CLL
Kidney function
eGFR ≥60 mL/min/1.73 m2
Liver function
Albumin ≥30 g/L; Bilirubin ≤1.5 times ULN (solid tumor) or ≤2 x ULN (CLL); ALT and AST ≤2.5 x ULN (solid tumor and CLL); If liver has tumor involvement, AST and ALT ≤5 x ULN are acceptable (solid tumor); Subjects with known Gilbert's Syndrome or disease-related hemolysis must have a total bilirubin ≤ 3 x ULN (CLL)
Cardiac function
No 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. No congestive heart failure (NYHA Class ≥3). No unstable angina pectoris, acute myocardial infarction, or stroke ≤12 months prior to enrollment. QTcF prolongation >450 msec.
Have adequate organ function including: Hematologic: ANC ≥1.5 x 10^9/L, Platelets ≥100 x 10^9/L, Hemoglobin ≥90 g/L. Hepatic: Albumin ≥30 g/L, Bilirubin ≤1.5 times ULN, ALT and AST ≤2.5 x ULN. If the liver has tumor involvement, AST and ALT ≤5 x ULN are acceptable. Renal: eGFR ≥60 mL/min/1.73 m2. Blood coagulation: INR or aPTT <1.5 x ULN and > 0.8 x LLN. CLL: WBC ≥3.0 x 10^9/L, ANC ≥1.0 x 10^9/L, Platelets ≥50 x 10^9/L or ≥25 x 10^9/L if thrombocytopenia is related to CLL. 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. Renal: eGFR ≥60 mL/min/1.73 m2. Blood coagulation: INR or aPTT <1.5 x ULN and > 0.8 x LLN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify