LS301-IT Imaging for Lung Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Integro Theranostics

Must not be taking: Fluorescent agents

Disqualifiers: Renal impairment, Cardiac abnormalities, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Robert Honigberg, MD

Principal Investigator

Integro Theranostics

Eligibility Criteria

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.

Known sensitivity to near infrared light

Trial Timeline

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

Treatment Details

Interventions

• LS301-IT (Fluorescence Imaging Agent)

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.

Participant Groups

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+