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Pemefolacianine for IMI of Lung Cancer

NCT07772895 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-19

No results posted yet for this study

Summary

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.

Conditions

  • Lung Cancer (Locally Advanced or Metastatic)

Interventions

DRUG

Pemefolacianine Cohort 1 in Part A

Enrolled 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

DRUG

Pemefolacianin Cohort 2 in Part B

Enrolled 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

Sponsors & Collaborators

  • Sunil Singhal

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-11
Primary Completion
2027-03-11
Completion
2027-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772895 on ClinicalTrials.gov