RecruitingPhase 1/2

Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

Ukraine36 participantsStarted 2024-05-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult (male or female) aged ≥18 years.
. Signed informed consent prior to any study-specific procedures.
. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.
. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of:
. Have an estimated life expectancy of ≥12 weeks.
. Have adequate organ function including:
. Have discontinued all chemotherapy, investigational therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since KLS-1 is being tested in a Phase 1/2 trial, what do we know so far about its safety profile, and how does the fact that they're still establishing safe doses affect the risk picture for someone in my situation?
2The trial is measuring 'dose-limiting toxicities' — can you explain what that means in plain terms, and what kinds of side effects I should be prepared to watch for if I were to participate in a study like this?
3This trial covers both CLL and solid tumors, which are very different cancers — given my specific diagnosis, do you think KLS-1 monotherapy addresses my tumor type in a way that's relevant to my case?
4Before considering a trial that's still in the dose-finding stage, are there established standard-of-care treatments I should try first, and how would participating in this study affect my access to those options later?
5The trial is actively recruiting right now — if you felt this could be worth exploring for me, how would I find out whether the specific dosing arm or patient criteria fit where I am in my treatment journey?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with Dose Limiting Toxicities (DLTs)

Timeframe: 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)

Timeframe: 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)

Number of participants with Treatment Emergent Serious Adverse Events (SAEs)

Number of participants with Overall Response Rate (ORR)

Timeframe: 30-Day Follow-up, Q 3-Months Follow-up, 12-Months Follow -up

Trial details

NCT IDNCT06506643

SponsorVector Vitale LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Max Temnik

+1 305 331-12 13 clinicaltrials@vectorvitale.com

View on ClinicalTrials.gov More CLL trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult (male or female) aged ≥18 years.
. Signed informed consent prior to any study-specific procedures.
. Patients who are willing to make themselves available for the duration of the study and are willing to follow study procedures.
. Have a performance status on the Eastern Cooperative Oncology Group (ECOG) scale of:
. Have an estimated life expectancy of ≥12 weeks.
. Have adequate organ function including:
. Have discontinued all chemotherapy, investigational therapy, molecularly targeted therapy, and cancer-related hormonal therapy at least 30 days prior to study enrollment (6 weeks for mitomycin-C or nitrosoureas).

What they're measuring

Number of participants with Dose Limiting Toxicities (DLTs)

Timeframe: 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)

Number of participants with Treatment Emergent Adverse Events (AEs)

Number of participants with Treatment Emergent Serious Adverse Events (SAEs)

Number of participants with Overall Response Rate (ORR)

Timeframe: 30-Day Follow-up, Q 3-Months Follow-up, 12-Months Follow -up

Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria