Pemefolacianine for IMI of Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunil Singhal
About this trial
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
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 or open surgery (thoracotomy) and resection of the lung.
If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
Disqualifiers
Contraindications for surgery or any medical condition that in the opinion of the investigator could significantly 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 (e.g., Cytalux)
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 fluorescent light
Trial design
Design model
Single group
Treatments tested in this trial
Pemefolacianine Cohort 1 in Part A
DrugEnrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 1 patients will receive dose of 0.02 mg/kg
Pemefolacianin Cohort 2 in Part B
DrugEnrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 2 patients will receive dose of 0.04 mg/kg
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Pemefolacianine Cohort 1Experimental treatment 1 intervention
Group B: Pemefolacianine Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety of Pemefolacianine for Injection, as assessed by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant changes in laboratory values, vital signs, physical examinations, and electrocardiograms (ECGs) from baseline through the end of the study.
Time frame
Day 1 through Day 30Secondary outcomes
1
Signal-to-Background Ratio in Intraoperative Tissue Images
Surgeon intraoperative semi-quantitative fluorescence assessments will be collected. Video images will be analyzed for fluorescence signal (eg, mean fluorescence intensity) and ratios (eg, signal-to-background, tumor/non-tumor) will be determined in various images and recorded. Descriptive statistics will be obtained and compared with histopathology and the surgeon's assessment of fluorescence in each tissue type.
Time frame
Day 2 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunil Singhal
Lead sponsor
Abramson Cancer Center at Penn Medicine
Sponsor institution
Source ClinicalTrials.gov