OncoMatch/Clinical Trials/NCT06506643
Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
Is NCT06506643 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06506643 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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