Actively Recruiting
Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
Led by Vector Vitale LLC · Updated on 2024-10-01
36
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women aged 18 years or older
- Signed informed consent before any study procedures
- Willing to be available and follow study procedures throughout the trial
- ECOG performance status 0 or 1 for Phase I; 0 to 2 for Phase II
- Estimated life expectancy of at least 12 weeks (Phase I) or 16 weeks (Phase II CLL cohort)
- Adequate organ function including blood counts, liver, kidney, and blood clotting within specified limits
- Discontinued all chemotherapy, investigational therapies, and cancer-related treatments at least 30 days before enrollment (6 weeks for some drugs)
- Fully recovered from recent radiation or surgery before joining the study
- Recovered or recovering from side effects of prior cancer treatments (Grade 1 or baseline, except alopecia or Grade 2 neuropathy)
- For CLL patients, confirmed diagnosis and measurable disease with specific blood or imaging criteria
- Received 1 to 4 prior systemic therapies for CLL (Phase I) or 1 to 3 prior therapies for Phase II CLL cohort
- Female patients with reproductive potential must use two highly effective contraception methods during the study and for 3 months after last dose; sexually active males must use barrier contraception
- Negative pregnancy test required for females with child-bearing potential before the first dose
- Patients must be appropriate candidates for experimental therapy with no standard treatments expected to benefit
- At least one measurable lesion by RECIST v1.1 (Phase I and II solid tumors)
- Histologically confirmed metastatic solid tumor (excluding brain tumors) with no approved effective therapy or declined standard treatment (Phase I)
- Locally advanced or metastatic solid tumors (cutaneous melanoma, prostate cancer, pancreatic cancer) with no approved effective therapy or declined standard treatment (Phase II)
You will not qualify if you...
- Having another tumor type except basal cell carcinoma
- History of organ transplant such as heart, lungs, liver, bone marrow, or kidney
- Pregnant or breastfeeding women
- Symptomatic HIV infection, known HIV positive, or chronic active hepatitis B or C
- Positive COVID-19 test or signs of coronavirus infection
- Significant heart disease including congenital long QT syndrome, serious arrhythmias, heart failure (class III or higher), recent heart attack or stroke within 12 months, or prolonged QT interval
- Taking medications that prolong QT interval that cannot be stopped or changed
- Uncontrolled diabetes with high risk of low blood sugar
- Being a family member of the investigator or study staff
- Currently participating in another interventional clinical trial
- Hypersensitivity to any components of KLS-1
- For Phase II CLL cohort, history of Richter's transformation or prolymphocytic leukemia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Centre of Arensia Exploratory Medicine LLC
Kyiv, Ukraine, 01135
Actively Recruiting
Research Team
M
Max Temnik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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