Clinical trial · Interventional
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
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 Cancer in the Lung
NCT06145048CI-TRIAL-00111427VISUALIZEcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Metastases | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VGT-309 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 0.32 mg/kg VGT-309
- description
- 0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump
- interventionNames
- Drug: VGT-309
Primary outcomes (1)
- measure
- Clinically Significant Events (CSE)
- timeFrame
- Day of surgery
- description
- Proportion of subjects with at least one Clinically Significant Event (CSE) as defined by: A. Intraoperative localization of one or more preoperatively identified lung lesions using VGT-309 with NIR imaging not found w/SOC; and confirmed by histologic examination to be other than normal lung tissue. B. Identification of one or more synchronous or occult lung lesions using VGT-309 with NIR imaging not found with SOC; and confirmed by histologic examination to be cancerous or precancerous. C. Identification of fluorescence within ≤10 mm from the inside edge of the closest staple line as measured by the investigator ex vivo in the operating room using NIR imaging, with pathologic margin confirmed by histologic examination to be ≤ 10 mm. D. Identification of lymph nodes by VGT-309 with NIR imaging confirmed by histologic examination to be cancerous.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be willing and able to sign the informed consent and comply with study procedures. 2. Be at least 18 years of age. 3. 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. 4. 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. 5. Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent 6. Have acceptable kidney and liver functions at study entry as evidenced by: ALT/AST \< 1.5 times the upper limit of normal Calculated Creatinine Clearance (CrCl) ≥ 50 ml/min Total bilirubin \< 1.5 times the upper limit of normal Have an ECOG score of 0-2. Meet all standard of care surgical and general anesthesia requirements. 7) Have not participated in an interventional clinical trial within the last 30 days. \- Exclusion Criteria: 1. Not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician. 2. Have a known allergy or reaction to ICG, other radiographic contrast agent, or any component of VGT-309. 3. Have congenital long QT syndrome or QTcF \> 470ms by history or at Screening ECG. 4. Prisoners, institutionalized individuals, or are unable to consent for themselves. 5. Have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.
References
Publications (0)
Data not yet available
No reference posted for this study.