Phase 2 Study of VGT-309 in Lung Cancer

NCT05400226 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VGT-309-2-2021USA1R44CA277890-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Clinically Significant Event (CSE)

  Identification of the proportion of subjects with at least one CSE as defined by: A. Localization of a Pulmonary Nodule using VGT-309 near-infrared (NIR) Imaging when white light and palpation failed to identify a nodule. B. Synchronous Lesion Identification using VGT-309 NIR Imaging when not identified by white light and palpation. C. Positive Margin Identification with only VGT-309 NIR Imaging when deemed negative by the surgeon by white light and palpation.

  Day of surgery

Secondary Outcomes (4)

• Sensitivity

  Day of surgery

• Negative Predictive Value

  Day of surgery

• Specificity

  Day of surgery

• Positive Predictive Value

  Day of surgery

Study Arms (1)

0.32mg/kg VGT-309

EXPERIMENTAL

Single arm in an open label study

Drug: VGT-309

Interventions

VGT-309 DRUG

VGT-309 is an tumor-targeted, activatable fluorescent imaging agent which will be used with near infrared imaging during surgery to identify tumor.

0.32mg/kg VGT-309

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to sign the informed consent and comply with study procedures.
• Be between the ages of 18 and 85, inclusive.
• Be male or female and meet the following conditions:
• Female participants must be of non-childbearing potential, or,
• If of childbearing potential be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30.
• Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-dose and agree not to donate semen during this waiting period.
• Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
• Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
• Intrauterine device or intrauterine hormone-releasing system
• NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above.
• They are required to maintain abstinence from screening through Day 30.
• Have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsy-proven.
• Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent and meet all pre-operative surgical and anesthesia acceptance criteria.
• Have acceptable kidney and liver functions at study entry as evidenced by:
• Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) \< 1.5 times the upper limit of normal

You may not qualify if:

• They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
• They have a known allergy or reaction to indocyanine green (ICG), other radiographic contrast agent, or any component of VGT-309.
• Have congenital long QT syndrome or QTcF \> 450ms (males) or \>470ms (females) by history or at Screening ECG.
• They are prisoners, institutionalized individuals, or are unable to consent for themselves.
• Have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Sponsors & Collaborators

• Vergent Bioscience, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Maggie Neptune
• Organization: Vergent Bio

mneptune@vergentbio.com

+1-510-410-9124

Study Officials

• Curt Scribner, MD

  Vergent Bioscience

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects to be dosed at the same dose level. This is open label and no randomization is required.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: May 24, 2022
• Primary Completion: June 24, 2023
• Study Completion: December 15, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)