LS301-IT Imaging for Lung Cancer

Overseen By Nicole Peterson

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Integro Theranostics

Must not be taking: Fluorescent agents

Disqualifiers: Renal impairment, Cardiac abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, LS301-IT, to evaluate its safety and effectiveness in detecting lung cancer. Researchers administer a single dose of the agent through an IV before surgery to help identify cancerous tissue during lung surgery. Participants receive varying doses to assess how timing and amount affect safety and imaging brightness. The trial seeks individuals diagnosed with or strongly suspected of having lung cancer who plan to undergo lung surgery. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LS301-IT is likely to be safe for humans?

Research has shown that LS301-IT, a new imaging agent for lung cancer, has promising safety results from earlier studies. It helps surgeons see cancer cells during surgery by making them light up. This experimental treatment is administered through an IV before surgery. Early findings suggest it is well-tolerated by patients, with no major safety concerns reported. As a Phase 1 study, the main goal is to assess its safety and tolerability. The treatment has been tested at different doses, all focusing on ensuring its safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LS301-IT because it offers a novel approach to lung cancer imaging. Unlike standard treatments that primarily focus on targeting cancer cells, LS301-IT is a fluorescent dye administered intravenously that enhances the visibility of cancerous tissues during surgery. This could potentially allow for more precise tumor removal, reducing the likelihood of leaving behind cancerous cells and improving surgical outcomes. The unique aspect of LS301-IT is its ability to illuminate tumors, which could revolutionize how surgeons identify and remove lung cancer tissues.

What evidence suggests that LS301-IT is effective for lung cancer?

Research has shown that LS301-IT is a promising new tool for imaging lung cancer. This substance attaches specifically to cancer cells, aiding doctors in seeing tumors more clearly during surgery. Early results suggest that LS301-IT is safe and can effectively highlight cancerous tissue, making it easier to detect. In studies, it has demonstrated potential to improve the accuracy of lung cancer surgeries by making cancer cells glow under a special light. This could lead to more precise tumor removal, marking a significant advancement in cancer treatment. Participants in this trial will receive different dosages of LS301-IT to evaluate its effectiveness and safety at various levels. ^{2 3 5 6 7}

Who Is on the Research Team?

Robert Honigberg, MD

Principal Investigator

Integro Theranostics

Are You a Good Fit for This Trial?

This trial is for individuals undergoing surgery for lung cancer. Participants must be eligible for surgical thoracoscopy and resection, meaning they are scheduled to have part of their lung surgically removed due to cancer.

Inclusion Criteria

I am diagnosed or suspected to have lung cancer based on scans or biopsy.

I can care for myself and am up and about more than 50% of my waking hours.

I am scheduled for a lung surgery involving a camera.

Exclusion Criteria

I have health issues that make surgery unsafe for me.

I haven't used any fluorescent imaging agents recently.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of dose limiting toxicities

2 to 7 days

1 visit (in-person)

Safety Review

Safety of each dose level is assessed by the Safety Review Committee to recommend subsequent dosing

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• LS301-IT

Trial Overview The study tests LS301-IT, a new imaging agent given by IV before surgery. It's designed to help surgeons see the cancer better during operation. The focus is on how safe it is and how well it works at different doses and times before surgery.

How Is the Trial Designed?

Group I: LS301-IT Cohort 3 Experimental Treatment 1 Intervention

0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Group II: LS301-IT Cohort 2 Experimental Treatment 1 Intervention

0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Group III: LS301-IT Cohort 1 Experimental Treatment 1 Intervention

0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Group IV: LS301-IT Cohort -1 Experimental Treatment 1 Intervention

0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Who Is Running the Clinical Trial?

Integro Theranostics

Lead Sponsor

Trials

2

Recruited

120+

Citations

1. integrotheranostics.com integrotheranostics.com/science

Science LS301 is a stable molecule that directly targets cancer cells. It selectively binds to an activated protein that is uniquely expressed by cancer cells.

2. firstwordpharma.com firstwordpharma.com/story/6094773

Promising Phase 1b Lung Cancer Surgery Clinical Trial ... Results indicate safety and preliminary efficacy of LS301 for intraoperative cancer visualization. SAINT LOUIS, MO, UNITED STATES, ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/560419

A Single Dose, Open-Label, Dose-escalation Study of the ... 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 ...

4. synapse.patsnap.com synapse.patsnap.com/drug/f3c106471d6c482997ca8121e2452d6a

LS301-IT - Drug Targets, Indications, Patents An Open-label, Single-arm, Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of LS301-IT in Female Patients Undergoing Partial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7135742/

Selective imaging of solid tumours via the calcium ... To test the ability of LS301 to detect tumour in models that mimic the pathophysiology of human cancer, we used the spontaneous MMTV-PyMT mouse model, whereby ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06713564

Study Details | NCT06713564 | A Single Dose, Open-Label ... 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 ...

7. withpower.com withpower.com/trial/ls301-it-imaging-for-lung-cancer-45599

LS301-IT Imaging for 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 ...