Epithelial Ovarian CancerPhase 1NCT07905677
Phase 1 Study of VT-101 in Advanced Ovarian Cancer
A Phase 1 study testing VT-101 in people with Epithelial Ovarian Cancer and Ovarian Cancer, run by Michael J. Goodheart.
Trial summary
This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Ovarian Cancer
- What is being tested?
- VT-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 23 Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Dose-Finding, Safety, and Preliminary Clinical Activity Study of VT-101 in Advanced Ovarian Cancer
This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for further study. Secondary and exploratory objectives include evaluation of preliminary antitumor activity and characterization of treatment-related effects in participants with limited standard treatment options.
Read the detailed description
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.
- Conditions
- Epithelial Ovarian Cancer, Ovarian Cancer
- Being tested
- VT-101
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-101Drug
VT-101 is an investigational therapy consisting of autologous M1 macrophage-derived vesicles generated through membrane fragmentation. VT-101 is administered intraperitoneally via an implanted port over approximately 45 minutes, once weekly on Days 1, 8, 15, and 22, for four doses. Phase I dose escalation follows a standard 3+3 design, beginning at 1 × 10⁸ vesicles per dose and escalating to 1 × 10⁹ and 1 × 10¹⁰ vesicles per dose. Each participant receives the same dose level. After the maximum tolerated dose is established, an expansion cohort will evaluate preliminary efficacy at that dose.
| Study group | Role | What they receive |
|---|---|---|
| VT-101 Dose Escalation and Expansion | Experimental | Participants will receive VT-101 by intraperitoneal administration once weekly for four doses on Days 1, 8, 15, and 22. During Phase I, doses will be escalated using a standard 3+3 design, starting at 1 × 10⁸ microvesicles (MVs) per dose, followed by 1 × 10⁹ and 1 × 10¹⁰ MVs per dose. Once the maximum tolerated dose (MTD) is determined, enrollment at the MTD will be expanded to include 10 patients in the efficacy evaluation. Patients treated at the MTD during Phase I will count toward this total. Receives: Drug: VT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities (DLTs) during Phase I dose escalation. The maximum tolerated dose (MTD) will be defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT.
Measured: From the first dose through 14 days after the Day 22 dose. This reflects the Phase I primary endpoint and the protocol's specified toxicity-monitoring window.
Overall Response Rate (ORR)
Proportion of participants achieving a complete response (CR) or partial response (PR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Participants who do not meet the criteria for an objective response will be considered non-responders.
Measured: Beginning 1 month after the fourth dose (±7 days), then every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or the end of study.
Secondary outcomes (2)
Proportion of Participants With a ≥50% Reduction in CA-125
Proportion of participants who achieve at least a 50% reduction in CA-125 levels relative to baseline.
Measured: From baseline to after 4 doses of VT-101 (Days 1, 8, 15, and 22).
Progression-Free Survival (PFS)
Time from treatment initiation to the first documented disease progression or death from any cause, whichever occurs first. Participants without documented progression or death will be censored at their last radiographic assessment for progression.
Measured: From treatment initiation until disease progression or death, with tumor imaging beginning 1 month after the fourth dose and then every 8 weeks for the first 12 months and every 12 weeks thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start23 Oct 2026 (estimated)
- Primary completion23 Oct 2029 (estimated)
- Study completion23 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael J. Goodheart
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael J. Goodheart, University of Iowa
- Investigators
- Michael Goodheart, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905677
- Sponsor's protocol ID
- 202608053
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Finding, Safety, and Preliminary Clinical Activity Study of VT-101 in Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07905677
- Acronym / sponsor ID
- 202608053
- Conditions
- Epithelial Ovarian Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Michael J. GoodheartUniversity, hospital or other
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 23 Oct 2029 (estimated)
- Study completion
- 23 Oct 2030 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for further study. Secondary and exploratory objectives include evaluation of preliminary antitumor activity and characterization of treatment-related effects in participants with limited standard treatment options.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VT-101 Dose Escalation and Expansion | Experimental | Drug: VT-101Participants will receive VT-101 by intraperitoneal administration once weekly for four doses on Days 1, 8, 15, and 22. During Phase I, doses will be escalated using a standard 3+3 design, starting at 1 × 10⁸ microvesicles (MVs) per dose, followed by 1 × 10⁹ and 1 × 10¹⁰ MVs per dose. Once the maximum tolerated dose (MTD) is determined, enrollment at the MTD will be expanded to include 10 patients in the efficacy evaluation. Patients treated at the MTD during Phase I will count toward this total. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- Female only
- 18 years and older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-101VT-101 is an investigational therapy consisting of autologous M1 macrophage-derived vesicles generated through membrane fragmentation. VT-101 is administered intraperitoneally via an implanted port over approximately 45 minutes, once weekly on Days 1, 8, 15, and 22, for four doses. Phase I dose escalation follows a standard 3+3 design, beginning at 1 × 10⁸ vesicles per dose and escalating to 1 × 10⁹ and 1 × 10¹⁰ vesicles per dose. Each participant receives the same dose level. After the maximum tolerated dose is established, an expansion cohort will evaluate preliminary efficacy at that dose. | Drug | VT-101 Dose Escalation and Expansion |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From the first dose through 14 days after the Day 22 dose. This reflects the Phase I primary endpoint and the protocol's specified toxicity-monitoring window.
Number of participants experiencing dose-limiting toxicities (DLTs) during Phase I dose escalation. The maximum tolerated dose (MTD) will be defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT.
Overall Response Rate (ORR)
Time frame: Beginning 1 month after the fourth dose (±7 days), then every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or the end of study.
Proportion of participants achieving a complete response (CR) or partial response (PR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Participants who do not meet the criteria for an objective response will be considered non-responders.
2 secondary outcomes
Proportion of Participants With a ≥50% Reduction in CA-125
Time frame: From baseline to after 4 doses of VT-101 (Days 1, 8, 15, and 22).
Progression-Free Survival (PFS)
Time frame: From treatment initiation until disease progression or death, with tumor imaging beginning 1 month after the fourth dose and then every 8 weeks for the first 12 months and every 12 weeks thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Goodheart, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VT-101 in people with Epithelial Ovarian Cancer and Ovarian Cancer, run by Michael J. Goodheart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Goodheart, MD (+1 319 356 2015, michael-goodheart@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: From the first dose through 14 days after the Day 22 dose. This reflects the Phase I primary endpoint and the protocol's specified toxicity-monitoring window.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.