RecruitingPhase 1Phase 2NCT06506643

Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

A Phase I/II Open-label Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of KLS-1 as Monotherapy in Patients With Malignant Neoplasms


Sponsor

Vector Vitale LLC

Enrollment

36 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer treatment called KLS-1 on its own (monotherapy) in patients with solid tumors. KLS-1 is a novel investigational drug, and this trial is designed to find the right dose, assess safety, and begin to understand how effective it is. The study has both a dose-finding phase (Phase I) and an effectiveness-testing phase (Phase II). **You may be eligible if...** - You are 18 or older with a confirmed solid tumor - Your cancer has no available effective standard treatment - You are in reasonably good health (ECOG 0–1 in Phase I, or 0–2 in Phase II) - You are expected to live at least 12 weeks - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - You have received chemotherapy or other cancer treatment in the last 3 weeks - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have active autoimmune disease or are on immunosuppressive drugs - You have serious heart, liver, or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZinc-64 Aspartate

KLS-1 drug substance is Zinc Aspartate enriched with isotope Zinc-64 to 99.2% mass fraction of total Zinc. KLS-1 investigational medicinal product (IMP) is formulated as a solution, containing 25.64 mg of drug substance in 1 ml and inactive ingredients (water for injections, USP, EuPh).


Locations(1)

Medical Centre of Arensia Exploratory Medicine LLC

Kyiv, Ukraine

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NCT06506643


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