Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVector Vitale LLC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 an estimated life expectancy of ≥12 weeks.
Disqualifiers
Have another tumor of another location except basal cell carcinoma.
Have a history of organ transplant (e.g., heart, lungs, liver, bone marrow, or kidney).
Females who are pregnant or breastfeeding.
Have symptomatic human immunodeficiency virus (HIV) infection, known HIV positive test results or have chronic active hepatitis B or C (screening is not required).
Trial design
Design model
Sequential
Treatments tested in this trial
Zinc-64 Aspartate
DrugKLS-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).
Treatment groups
36 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: KLS-1 dose escalation Phase I - Cohort 1: 2.0 mg/kgExperimental treatment 1 intervention
Group B: KLS-1 dose escalation Phase I - Cohort 2: 3.0 mg/kgExperimental treatment 1 intervention
Group C: KLS-1 dose escalation Phase I - Cohort 3: 3.9 mg/kgExperimental treatment 1 intervention
Group D: KLS-1 dose escalation Phase I - Cohort 4: 4.75 mg/kgExperimental treatment 1 intervention
Group E: KLS-1 dose escalation Phase I - Cohort 5: 6.5 mg/kgExperimental treatment 1 intervention
Group F: KLS-1 dose expansion Phase II cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Dose Limiting Toxicities (DLTs)
Dose Limiting Toxicities (DLTs) at Dose Escalation Cohorts
Time frame
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)2
Number of participants with Dose Limiting Toxicities (DLTs)
Dose Limiting Toxicities (DLTs) at Dose Confirmation Cohorts
Time frame
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)3
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
Time frame
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)4
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
Time frame
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)Secondary outcomes
1
Cmax of KLS-1
PK parameters: maximum plasma concentration (Cmax) of KLS-1
Time frame
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)2
AUC0-t and AUC0-∞ of KLS-1
PK parameters: area under the plasma concentration-time curve (AUC0-t and AUC0-∞) of KLS-1
Time frame
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)3
T1/2 of KLS-1
PK parameters: Half-Life (T1/2) of KLS-1
Time frame
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)4
Tmax of KLS-1
PK parameters: time to reach maximum plasma concentration (Tmax) of KLS-1
Time frame
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)Sponsors and contacts
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Source ClinicalTrials.gov