Breast CancerPhase 1/2NCT05900986
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
A Phase 1/2 study testing LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg and LS301-IT 0.075 mg/kg in people with Breast Cancer and DCIS, run by Integro Theranostics at 9 sites in United States.
Trial summary
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
- What is being tested?
- LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg and LS301-IT 0.075 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Jul 2023to 6 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy.
- ECOG performance status of 0 to 2
Who cannot join
- Contraindications for surgery.
- Simultaneous bilateral lumpectomies and bilateral partial mastectomies.
- History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study
- Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1.
- Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT.
- History of radiation therapy to the chest.
- The lymphatic imaging agent ICG cannot be used prior to the partial mastectomy and SLNB procedures on the day of surgery.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Integro Theranostics Research Site #10
Cleveland, Ohio, 44195
Integro Theranostics Research Site #3
Dallas, Texas, 75290
Integro Theronostics Research Site #1
Houston, Texas, 77030
Integro Theranostics Research Site #5
Philadelphia, Pennsylvania, 19107
Integro Theranostics Research Site #2
Scottsdale, Arizona, 85260
Integro Theranostics Research Site #6
The Bronx, New York, 10461
Integro Theranostics Research Site #12
Washington D.C., District of Columbia, 20059
Integro Theranostics Research Site #9
Weston, Florida, 33331
Integro Theranostics Clinical Research Site #8
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open-label, Single-arm, Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of LS301-IT in Female Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma in Situ (DCIS) or Stage I-II Primary Invasive Breast Cancer
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.
Read the detailed description
This is a Phase 1b/Phase 2, open-label study to investigate the use of LS301-IT (investigational medicinal product [IMP]), a fluorescence imaging agent used for visualization of tumor margins and SLNs in female patients with DCIS or Stage I-II, primary invasive carcinoma of the breast, for which the patient's primary surgical treatment is partial mastectomy.
Eligible patients will be enrolled into either:
- Phase 1b (Period 1): dose finding (escalation/de-escalation), and dose timing adjustment;
- Phase 2a (Period 2): expanded sample size based on acceptable dosing regimen, that being the dose level(s) and time interval between LS301-IT injection and surgery, determined in Period 1; or
- Period 2b (Period 3): allow surgeon to make additional surgical decisions based on fluorescence imaging findings during surgery (Period 3 will not be opened until results are available from Periods 1 and 2 and further FDA consultation is obtained).
- Conditions
- Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
- Being tested
- LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg, LS301-IT 0.075 mg/kg, LS301-IT 0.1 mg/kg
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS301-IT 0.025 mg/kgDrug
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/kgDrug
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/kgDrug
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/kgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LS301-IT | Experimental | LS301-IT will be administered by IV injection Receives: Drug: LS301-IT 0.025 mg/kg; Drug: LS301-IT 0.05 mg/kg; Drug: LS301-IT 0.075 mg/kg; Drug: LS301-IT 0.1 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with treatment-related adverse events
Measured: 30 days
Pharmacodynamics
Tumor to non-tumor ratio fluorescence response
Measured: during surgery
Pharmacodynamics
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
Measured: During surgery
Cmax
maximum observed plasma concentration main metabolite in plasma.
Measured: 24 hours
AUCinf
area under the plasma concentration time curve from time 0 extrapolated to infinite time
Measured: 24 hours
AUClast
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
Measured: 24 hours
Tmax
time to reach maximal plasma concentration (Tmax)
Measured: 24 hours
t1/2
elimination/apparent terminal elimination half life
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start14 Jul 2023
- Primary completion6 Oct 2025
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integro Theranostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Thompson, Study director, Integro Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900986
- Sponsor's protocol ID
- LS301-IT-B101
- Status last verified
- May 2026
- First submitted
- 10 May 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of LS301-IT in Female Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma in Situ (DCIS) or Stage I-II Primary Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT05900986
- Acronym / sponsor ID
- LS301-IT-B101
- Conditions
- Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Integro TheranosticsIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.
Detailed description
This is a Phase 1b/Phase 2, open-label study to investigate the use of LS301-IT (investigational medicinal product [IMP]), a fluorescence imaging agent used for visualization of tumor margins and SLNs in female patients with DCIS or Stage I-II, primary invasive carcinoma of the breast, for which the patient's primary surgical treatment is partial mastectomy.
Eligible patients will be enrolled into either:
- Phase 1b (Period 1): dose finding (escalation/de-escalation), and dose timing adjustment;
- Phase 2a (Period 2): expanded sample size based on acceptable dosing regimen, that being the dose level(s) and time interval between LS301-IT injection and surgery, determined in Period 1; or
- Period 2b (Period 3): allow surgeon to make additional surgical decisions based on fluorescence imaging findings during surgery (Period 3 will not be opened until results are available from Periods 1 and 2 and further FDA consultation is obtained).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LS301-IT | Experimental | Drug: LS301-IT 0.025 mg/kg, Drug: LS301-IT 0.05 mg/kg, Drug: LS301-IT 0.075 mg/kg, Drug: LS301-IT 0.1 mg/kgLS301-IT will be administered by IV injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy.
- ECOG performance status of 0 to 2
Key exclusion criteria (7 listed)
- Contraindications for surgery.
- Simultaneous bilateral lumpectomies and bilateral partial mastectomies.
- History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study
- Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1.
- Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LS301-IT 0.025 mg/kgThe 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 |
| LS301-IT 0.05 mg/kgDepending 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 |
| LS301-IT 0.075 mg/kgDepending 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 |
| LS301-IT 0.1 mg/kgDepending 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 |
Primary outcome
Adverse Events
Time frame: 30 days
Number of participants with treatment-related adverse events
Pharmacodynamics
Time frame: during surgery
Tumor to non-tumor ratio fluorescence response
Pharmacodynamics
Time frame: During surgery
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
Cmax
Time frame: 24 hours
maximum observed plasma concentration main metabolite in plasma.
AUCinf
Time frame: 24 hours
area under the plasma concentration time curve from time 0 extrapolated to infinite time
AUClast
Time frame: 24 hours
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
Tmax
Time frame: 24 hours
time to reach maximal plasma concentration (Tmax)
t1/2
Time frame: 24 hours
elimination/apparent terminal elimination half life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Thompson study director
Integro Theranostics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg and LS301-IT 0.075 mg/kg in people with Breast Cancer and DCIS, run by Integro Theranostics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.