Overview
This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. Eligible participants must have disease that has progressed following prior therapy or have exhausted, refused, become intolerant of, or are otherwise ineligible for available standard treatment options.
Participants will receive VT-101 administered according to a dose-escalation design to evaluate the safety profile of escalating dose levels and to identify an appropriate dose and schedule for further clinical development. Safety assessments will include the evaluation of adverse events, serious adverse events, dose-limiting toxicities, clinical laboratory parameters, physical examinations, vital signs, and other protocol-specified assessments.
Pharmacokinetic analyses will be performed to characterize the absorption, distribution, metabolism, and elimination of VT-101. Antitumor activity will be assessed using protocol-defined efficacy endpoints, including tumor response and disease control measures. Exploratory analyses may evaluate biomarkers and other factors associated with treatment response and clinical outcomes.
The information generated from this study will support determination of the safety profile, pharmacokinetic characteristics, and recommended dose of VT-101 for subsequent clinical investigation in patients with advanced epithelial ovarian cancer.
Principal investigator
Eligibility criteria
* Female participant
* Age ≥ 18 years
* Histologically confirmed advanced, recurrent, or relapsed epithelial ovarian cancer
* Has received prior standard therapy for ovarian cancer, OR has refused standard therapy, OR is intolerant to standard therapy, OR is not eligible for standard therapy
* ECOG Performance Status of 0, 1, or 2
* Adequate bone marrow, liver, and kidney function as defined by the protocol
* Able to comply with study procedures and provide informed consent
* For women of childbearing potential: agrees to use protocol-required contraception and meets pregnancy testing requirements Exclusion Criteria (high-level):
* Does not meet the inclusion criteria
* Medical conditions or laboratory abnormalities that would make study participation unsafe
* Other protocol-defined exclusions as determined by the investigator Sex: • Female only Age:
* 18 years and older
* No upper age limit specified Healthy Volunteers:
* No
* Healthy volunteers are not eligible
* Participants must have advanced, recurrent, or relapsed epithelial ovarian cancer
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