Lung CancersPhase 1NCT06713564
A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
A Phase 1 study testing LS301-IT in people with Lung Cancers, run by Integro Theranostics at 1 site in United States.
Trial summary
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancers
- What is being tested?
- LS301-IT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to 6 May 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status of 0 to 2
- Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
- Are scheduled to undergo surgical thoracoscopy and resection of the lung.
Who cannot join
- Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
- No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery
- History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
- Known sensitivity to near infrared light
- Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
- History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) > 470 ms
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 1b, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.
Read the detailed description
This is a Phase 1b, 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 other suspicious nodules in patients with primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
Up to 24 patients (4 dose cohorts, up to 6 patients each) for Phase 1b study (total of 24 patients maximum). There will be no stratification by dosing interval or lung cancer type (e.g., lung adenocarcinoma, lung squamous cell carcinoma).
As safety is the primary objective of this study, the safety of each dose level will be assessed by the Safety Review Committee (SRC). Based upon the safety results of the first cohort, the SRC will recommend to the Sponsor which dose levels of LS301-IT may be administered in subsequent cohorts.
- Conditions
- Lung Cancers
- Being tested
- LS301-IT
- Keywords
- lung cancer imaging, lung cancer surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS301-ITDrug
LS301 is composed of: 1) a cyclic peptide that binds phosphorylated Annexin A2 (ANXA2) which is found on the surface of malignant cells typically located in solid tumors and in malignant lymph nodes; and 2) cypate, a near infrared (NIR) molecule conjugated to the peptide, which fluoresces when illuminated using NIR light.
| Study group | Role | What they receive |
|---|---|---|
| LS301-IT Cohort -1 | Experimental | 0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery Receives: Drug: LS301-IT |
| LS301-IT Cohort 1 | Experimental | 0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery Receives: Drug: LS301-IT |
| LS301-IT Cohort 2 | Experimental | 0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery Receives: Drug: LS301-IT |
| LS301-IT Cohort 3 | Experimental | 0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery Receives: Drug: LS301-IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Dose Limiting Toxicities
Dose Limiting Toxicity - Any CTCAE Grade 2, 3, 4, or 5 AE (any treatment emergent sign or symptom) at least possibly related to IMP will be considered a DLT, as well as any other AE deemed clinically relevant by the SRC.
Measured: 2 to 7 days after dosing
Number of Patients that discontinue the study or have their surgery cancelled due to toxicity
Treatment discontinuation and/or surgery cancellation due to toxicity (hypersensitivity reaction to LS301-IT)
Measured: From start of dosing to time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start7 Nov 2024
- Primary completion6 May 2026
- 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 Lung CancersStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A single-dose, open-label, dose-escalation Phase 1b study in patients scheduled to undergo minimally invasive surgery (MIS) for known or suspected lung cancer via thoracoscopy (i.e., VATS). Single dose IV administration of LS301-IT, either on the day before surgery with 4 different doses in cohorts between 3 to 6 patients starting at a dose of 0.025 mg/kg with escalation or de-escalation. The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and VATS (Video-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integro Theranostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Honigberg, MD, Study director, Integro Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713564
- Sponsor's protocol ID
- LS301-IT-B102
- Status last verified
- May 2026
- First submitted
- 19 Nov 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
- ClinicalTrials.gov ID
- NCT06713564
- Acronym / sponsor ID
- LS301-IT-B102
- Conditions
- Lung Cancers
- Keywords
- lung cancer imaging, lung cancer surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Integro TheranosticsIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 3 Dec 2024 (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 study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.
Detailed description
This is a Phase 1b, 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 other suspicious nodules in patients with primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
Up to 24 patients (4 dose cohorts, up to 6 patients each) for Phase 1b study (total of 24 patients maximum). There will be no stratification by dosing interval or lung cancer type (e.g., lung adenocarcinoma, lung squamous cell carcinoma).
As safety is the primary objective of this study, the safety of each dose level will be assessed by the Safety Review Committee (SRC). Based upon the safety results of the first cohort, the SRC will recommend to the Sponsor which dose levels of LS301-IT may be administered in subsequent cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- A single-dose, open-label, dose-escalation Phase 1b study in patients scheduled to undergo minimally invasive surgery (MIS) for known or suspected lung cancer via thoracoscopy (i.e., VATS). Single dose IV administration of LS301-IT, either on the day before surgery with 4 different doses in cohorts between 3 to 6 patients starting at a dose of 0.025 mg/kg with escalation or de-escalation. The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and VATS (Video-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
| Arm | Type | Receives |
|---|---|---|
| LS301-IT Cohort -1 | Experimental | Drug: LS301-IT0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery |
| LS301-IT Cohort 1 | Experimental | Drug: LS301-IT0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery |
| LS301-IT Cohort 2 | Experimental | Drug: LS301-IT0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery |
| LS301-IT Cohort 3 | Experimental | Drug: LS301-IT0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ECOG performance status of 0 to 2
- Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
- Are scheduled to undergo surgical thoracoscopy and resection of the lung.
Key exclusion criteria (6 listed)
- Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
- No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery
- History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
- Known sensitivity to near infrared light
- Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
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-ITLS301 is composed of: 1) a cyclic peptide that binds phosphorylated Annexin A2 (ANXA2) which is found on the surface of malignant cells typically located in solid tumors and in malignant lymph nodes; and 2) cypate, a near infrared (NIR) molecule conjugated to the peptide, which fluoresces when illuminated using NIR light. | Drug | LS301-IT Cohort -1, LS301-IT Cohort 1, LS301-IT Cohort 2, LS301-IT Cohort 3 |
Primary outcome
Number of Patients with Dose Limiting Toxicities
Time frame: 2 to 7 days after dosing
Dose Limiting Toxicity - Any CTCAE Grade 2, 3, 4, or 5 AE (any treatment emergent sign or symptom) at least possibly related to IMP will be considered a DLT, as well as any other AE deemed clinically relevant by the SRC.
Number of Patients that discontinue the study or have their surgery cancelled due to toxicity
Time frame: From start of dosing to time of surgery
Treatment discontinuation and/or surgery cancellation due to toxicity (hypersensitivity reaction to LS301-IT)
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 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Robert Honigberg, MD study director
Integro Theranostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LS301-IT in people with Lung Cancers, run by Integro Theranostics at 1 site 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 3 inclusion and 6 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 19 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 1 site 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 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.
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?
Number of Patients with Dose Limiting Toxicities (time frame: 2 to 7 days after dosing). The study lists 2 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 19 May 2026.