Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506643
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-07
Brief Title:
Safety and Efficacy of KLS-1 Monotherapy in Malignant Neoplasms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is a Phase III open-label non-randomized multicenter study of KLS-1 administered via intravenous IV infusions in 21-day treatment cycles to adult participants with different types of solid tumors and CLL
Phase I a dose-escalation part will explore multiple-dose levels PK and select a single dose level to explore in Phase II of the study A conventional 33 design will be utilized Once a dose level is selected the additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose P2D Phase II a dose expansion part will evaluate the evidence of anti-tumor activity of the selected dose in four dose expansion cohorts of patients with different types of solid locally advanced andor metastatic tumors or CLL The study is designed to identify and characterize the safety tolerability efficacy and PK profile of KLS-1 in oncological patients
Phase I a dose-escalation part will explore multiple-dose levels PK and select a single dose level to explore in Phase II of the study A conventional 33 design will be utilized Once a dose level is selected the additional cohort of 3-6 patients will be enrolled to assess more effectively the safety during 2 treatment cycles and confirm Phase II dose P2D Phase II a dose expansion part will evaluate the evidence of anti-tumor activity of the selected dose in four dose expansion cohorts of patients with different types of solid locally advanced andor metastatic tumors or CLL The study is designed to identify and characterize the safety tolerability efficacy and PK profile of KLS-1 in oncological patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None