LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 14, 2023

Primary Completion Date

October 6, 2025

Study Completion Date

May 31, 2026

Conditions
Breast CancerDCISInvasive Duct Carcinoma of Breast
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (9)

10461

Integro Theranostics Research Site #6, The Bronx

19107

Integro Theranostics Research Site #5, Philadelphia

20059

Integro Theranostics Research Site #12, Washington D.C.

27103

Integro Theranostics Clinical Research Site #8, Winston-Salem

33331

Integro Theranostics Research Site #9, Weston

44195

Integro Theranostics Research Site #10, Cleveland

75290

Integro Theranostics Research Site #3, Dallas

77030

Integro Theronostics Research Site #1, Houston

85260

Integro Theranostics Research Site #2, Scottsdale

Sponsors
All Listed Sponsors
lead

Integro Theranostics

INDUSTRY