BridgeMD
New treatment option for Participants With Advanced Solid Tumor Malignancies
Official title First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT07136779
What this study is testing
What is VBC101?
VBC101 is an investigational medicine, being studied as a potential treatment for participants with advanced solid tumor malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify the MTD and/or RP2D with potential backfill cohorts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A participant must meet all of the following to be eligible to participate in this trial:
- 1\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial...
- 2\. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard...
- 3\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
- 4\. Male or female adults (defined as ≥ 18 years of age)
You likely can't join if
- 1\. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes...
- 2\. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without...
- 3\. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
- 4\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
- 5\. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe...
See the full eligibility criteria
- A participant must meet all of the following to be eligible to participate in this trial:
- 1\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- 2\. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for...
- 3\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
- 4\. Male or female adults (defined as ≥ 18 years of age)
- 5\. ECOG performance status 0-1
- 6\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
- 7\. Life expectancy greater than 12 weeks
- 8\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- 9\. Adequate organ and bone marrow function
- 10\. Participants must meet the minimum washout period requirements before the first dose of investigational drug
- 1\. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to...
- 2\. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10...
- 3\. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
- 4\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
- 5\. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are...
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; Houston, Texas, United States; San Antonio, Texas, United States; West Valley City, Utah, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.