Phase 2 N=89 Treatment

Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.

Lung Cancer · Lung Metastases

Bottom Line

View on ClinicalTrials.gov: NCT06145048 ↗

Enrolled (actual)

Serious AEs

13.5%

Results posted

May 2026

Primary outcome: Primary: Clinically Significant Events (CSE) — 0.449 Proportion of subjects — p=<.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VGT-309 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vergent Bioscience, Inc.
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinically Significant Events (CSE)	0.449	<.0001 sig
SECONDARY 1 - Positive Predictive Value	0.250	—
SECONDARY Positive Predictive Value	0.750	—
SECONDARY Sensitivity	0.841	—

Summary

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives.

Eligibility Criteria

Inclusion Criteria

Be willing and able to sign the informed consent and comply with study procedures.
Be at least 18 years of age.
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 after treatment.

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 after treatment 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: Subjects 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 after treatment.

Note: Subjects in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids.

Have a lung nodule or mass that might be considered primary lung cancer or lung metastases whether or not it is biopsy-proven before surgery.
Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent
Have acceptable kidney and liver functions at study entry as evidenced by:

ALT/AST 470ms by history or at Screening ECG.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06145048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.