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New treatment option for Participants With Advanced Solid Tumor Malignancies
Official title Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT07299747
What this study is testing
What is VBC103?
VBC103 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 study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I/IIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), PK and further evaluate its efficacy.
- 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
- 1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures.
- 2.Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard...
- 3.At least one measurable lesion as assessed by the investigator per RECIST v1.1.
- 4.Adult male or female (defined as ≥18 years of age)
- 5.ECOG performance status score of 0-1.
You likely can't join if
- 1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy.
- 2.Known active keratitis or corneal ulcer.
- 3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation...
- 4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational...
See the full eligibility criteria
- 1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures.
- 2.Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard...
- 3.At least one measurable lesion as assessed by the investigator per RECIST v1.1.
- 4.Adult male or female (defined as ≥18 years of age)
- 5.ECOG performance status score of 0-1.
- 6.LVEF ≥50% as measured by ECHO or MUGA within 28 days prior to enrollment.
- 7.Life expectancy exceeding 12 weeks.
- 8.Availability of archived tumor tissue samples or willingness to undergo biopsy sampling.
- 1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy.
- 2.Known active keratitis or corneal ulcer.
- 3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation pneumonitis), current interstitial lung disease, or suspected interstitial lung...
- 4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational product, severe asthma, severe chronic obstructive pulmonary disease...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 Shanghai, Shanghai Municipality, China. 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.