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Phase 1 Study of VT-101 in Advanced Ovarian Cancer

4. november 2026 opdateret af: Michael J. Goodheart

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

22

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Dose-Limiting Toxicities (DLTs)
Tidsramme: 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.
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)
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With a ≥50% Reduction in CA-125
Tidsramme: From baseline to after 4 doses of VT-101 (Days 1, 8, 15, and 22).

Proportion of participants who achieve at least a 50% reduction in CA-125 levels relative to baseline.
From baseline to after 4 doses of VT-101 (Days 1, 8, 15, and 22).
Progression-Free Survival (PFS)
Tidsramme: 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.

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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Michael J. Goodheart

Efterforskere

  • Ledende efterforsker: Michael Goodheart, MD, University of Iowa

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. oktober 2026

Primær færdiggørelse (Anslået)

23. oktober 2029

Studieafslutning (Anslået)

23. oktober 2030

Datoer for studieregistrering

Først indsendt

23. oktober 2026

Først indsendt, der opfyldte QC-kriterier

23. oktober 2026

Først opslået (Faktiske)

29. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202608053

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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