Recruiting
Phase 1

VT-101

Sponsor:

Michael J. Goodheart

Code:

NCT07905677

Conditions

Epithelial Ovarian Cancer

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VT-101

Study Details

Brief 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 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.

Conditions

Epithelial Ovarian Cancer

Ovarian Cancer

Study ID

NCT07905677

Start date

Oct 26, 2026

Status verified date

Oct, 2026

Completion date

Oct 23, 2030

Anticipated

Primary completion date

Oct 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VT-101 Dose Escalation and Expansion

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.

Interventions

VT-101

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.

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Michael Goodheart, MD

+1 319 356 2015michael-goodheart@uiowa.edu

Locations

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Michael Goodheart, MD

michael-goodheart@uiowa.edu

Kerri Fitch

(319) 467-5838kerri-fitch@uiowa.edu

More Information

Sponsor

Michael J. Goodheart

Last update posted

Nov 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Michael J. Goodheart on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.