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Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

NCT06506643 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • CLL
  • Solid Tumor, Adult

Interventions

DRUG

Zinc-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).

Sponsors & Collaborators

  • Vector Vitale LLC

    lead INDUSTRY

Principal Investigators

  • Prof. Valerii Cheshuk, MD, PhD · Medical Centre of Arensia Exploratory Medicine LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2026-07-31
Completion
2026-10-31

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506643 on ClinicalTrials.gov