VT-101 in Advanced Ovarian Cancer: early safety study in adults
Official title: A Phase 1 Dose-Finding, Safety, and Preliminary Clinical Activity Study of VT-101 in Advanced Ovarian Cancer
Run by University of Iowa · NCT07905677 · Data updated 2026-11-12
This early-phase trial tests VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer to see if it is safe, how the body handles it, and whether there are any initial signs of activity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | Women only |
| Enrollment | 22 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Status | Recruiting |
| Started | October 26, 2026 |
| Main results expected | October 23, 2029 |
| Study ends | October 23, 2030 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07905677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (≥18) with advanced, recurrent, or relapsed epithelial ovarian cancer who have had prior therapy or are ineligible or intolerant to standard options.
✕Probably not a fit
Patients without treatment-related responses or those who do not tolerate VT-101 may not experience benefit from this early-phase study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of VT-101 in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. Participants will receive escalating doses of VT-101 to determine a safe and potentially effective dose and schedule. Safety assessments will monitor adverse events and laboratory parameters, while PK analyses characterize absorption, distribution, metabolism, and elimination. Efficacy endpoints and exploratory biomarker analyses will provide early signals of activity and potential correlates of response. The study aims to inform dosing for future trials in patients with limited standard treatment options.
Why it matters
Potential benefit: If successful, participants may experience stabilization of disease or tumor shrinkage at the studied dose, along with information that could guide future therapies.
How similar studies have gone: Early-phase, dose-escalation trials in similar novel therapies have shown safety signals and potential activity to justify further development.
Who can join: the full rules
Show full inclusion / exclusion criteria
ELIGIBILITY CRITERIA Inclusion 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
Where it's running
-
University of Iowa Health Care
Iowa City, Iowa, United States Recruiting
Study contacts
- Principal investigator: Michael Goodheart, MD — University of Iowa
- Study coordinator: Michael Goodheart, MD
- Email: michael-goodheart@uiowa.edu
- Phone: +1 319 356 2015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.