100
Participants
Start Date
July 14, 2023
Primary Completion Date
October 6, 2025
Study Completion Date
May 31, 2026
LS301-IT 0.025 mg/kg
The dose of LS301-IT planned to be administered to the first cohort of patients is 0.025 mg/kg. Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased (by 50% as necessary). The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.
LS301-IT 0.05 mg/kg
Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased. The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.
LS301-IT 0.075 mg/kg
Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased. The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.
LS301-IT 0.1 mg/kg
Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased. The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.
Integro Theranostics Research Site #6, The Bronx
Integro Theranostics Research Site #5, Philadelphia
Integro Theranostics Research Site #12, Washington D.C.
Integro Theranostics Clinical Research Site #8, Winston-Salem
Integro Theranostics Research Site #9, Weston
Integro Theranostics Research Site #10, Cleveland
Integro Theranostics Research Site #3, Dallas
Integro Theronostics Research Site #1, Houston
Integro Theranostics Research Site #2, Scottsdale
Lead Sponsor
Integro Theranostics
INDUSTRY