Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
NCT Number: NCT06506643
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: CLL|Solid Tumor, Adult
Interventions: DRUG: Zinc-64 Aspartate
Sponsor: Vector Vitale LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2026-10-31
Locations: Medical Centre of Arensia Exploratory Medicine LLC, Kyiv, 01135, Ukraine

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). 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.

Primary Outcome Measures: Number of participants with Dose Limiting Toxicities (DLTs), Dose Limiting Toxicities (DLTs) at Dose Escalation Cohorts, 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, 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, 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, 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, 30-Day Follow-up, Q 3-Months Follow-up, 12-Months Follow -up
Secondary Outcome Measures: Cmax of KLS-1, PK parameters: maximum plasma concentration (Cmax) of KLS-1, 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, 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, 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, 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, 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, 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)), 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, 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)