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A Phase 3 Trial in Advanced Epithelioid Mesothelioma (sTEADfast)

11. september 2026 oppdatert av: Vivace Therapeutics, Inc

A Phase 3, Randomized, Open-label Trial Comparing VT3989 Versus Gemcitabine or Vinorelbine in Participants With Advanced Epithelioid Mesothelioma, Who Previously Received Platinum-Based Systemic Chemotherapy and Immunotherapy

This randomized, open-label, multicenter Phase 3 trial will compare VT3989 with Investigator's choice of gemcitabine or vinorelbine in adults with advanced epithelioid pleural mesothelioma whose disease progressed after prior platinum-based systemic chemotherapy and immunotherapy.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Approximately 350 participants will be randomized 1:1 to VT3989 (Arm A) or Investigator's choice chemotherapy with gemcitabine or vinorelbine (Arm B).

VT3989 will be administered orally at 100 mg once daily for 2 weeks on treatment followed by 2 weeks off treatment in each 4-week cycle. Comparator treatment will be gemcitabine or vinorelbine using the protocol-specified regimen or local prescribing/institutional practice.

The trial includes screening, treatment, safety follow-up, and survival follow-up periods. A QTc Sub-Study will evaluate cardiac repolarization using time-matched pharmacokinetic samples and ECGs in approximately 25 Arm A participants. Overall survival is the primary endpoint; BICR-assessed progression-free survival is the key secondary endpoint.

Studietype

Intervensjonell

Registrering (Antatt)

350

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Male or female, age 18 years or older at informed consent.
  • Pathologically confirmed advanced epithelioid pleural mesothelioma previously treated with platinum-based systemic chemotherapy and immunotherapy, given sequentially or concurrently.
  • Radiologically measurable disease by modified RECIST v1.1 or RECIST v1.1.
  • ECOG: 0-1.
  • Adequate organ functions, including the liver, kidneys, and hematopoietic system.

Exclusion Criteria:

  • Active brain metastases or primary CNS (central nervous system) tumors.
  • History of leptomeningeal metastases
  • Active or chronic, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Known HIV positive or active Hepatitis B or Hepatitis C
  • Clinically significant cardiovascular disease and prior exposure to cardiotoxic agents
  • Corrected QT (QTcF) interval > 470 msec (using Fridericia's correction formula).
  • Women who are pregnant or breastfeeding
  • Non-pleural mesothelioma at initial diagnosis or an aggressive histologic type such as sarcomatoid or biphasic mesothelioma.
  • Prior treatment with a TEAD inhibitor, including VT3989 or another agent targeting the same molecular pathway.
  • Prior receipt of both comparator treatments, gemcitabine and vinorelbine, alone or in combination, or known hypersensitivity to both. A participant who received only one comparator may enroll but must not be assigned to that same comparator.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A - VT3989
VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.
Legemiddel: VT3989
• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
Aktiv komparator: Arm B - Investigator's Choice Chemotherapy
The Investigator selects 21-day cycle of gemcitabine or vinorelbine. Administration and dose modification may follow the protocol, local prescribing information, or institutional practice.
Legemiddel: gemcitabine
• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
Legemiddel: Vinorelbine
• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Approximately 32-35 months after first randomization
Time from randomization to death from any cause. Participants without an observed death will be censored at the last date known alive or the analysis cut-off date, whichever is earlier.
Approximately 32-35 months after first randomization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival by BICR
Tidsramme: From randomization through radiologic progression, death, up to approximately 3 years or more
Time from randomization to the first BICR-assessed radiologic progressive disease or death, using protocol-defined censoring rules.
From randomization through radiologic progression, death, up to approximately 3 years or more
Treatment-Emergent Adverse Events and Serious Adverse Events
Tidsramme: From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
Incidence and severity of Treatment-Emergent Adverse Events and Serious Adverse Events
From first dose through the safety follow-up visit, (28 days after the last dose), up to approximately 3 years or more.
Disease-related symptoms and health-related quality of life outcomes
Tidsramme: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Disease-related symptoms, treatment side effects, functioning, and health-related quality of life outcomes and time to deterioration.
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Overall Response Rate by BICR
Tidsramme: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Overall Response Rate by BICR Proportion with best overall response of complete response or partial response by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Duration of Response
Tidsramme: From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
Among participants with a complete or partial response, time from first documented response to progressive disease or death, with protocol-defined censoring.
From first documented response through progression, death, or analysis cut-off; up to approximately 3 years or more
Disease Control Rate by BICR
Tidsramme: Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Proportion with best overall response of complete response, partial response, or stable disease by RECIST v1.1 and/or modified RECIST v1.1, assessed by BICR.
Tumor assessments during treatment and applicable follow-up; up to approximately 3 years or more
Time to Response
Tidsramme: From randomization to first documented response; up to approximately 3 years or more
Time from randomization to the first documented complete or partial response by RECIST v1.1 and/or modified RECIST v1.1.
From randomization to first documented response; up to approximately 3 years or more
EORTC QLQ-LC13
Tidsramme: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Lung cancer- and treatment-related symptoms using the EORTC Quality of Life Questionnaire Lung Cancer Module 13.
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
EQ-5D-5L
Tidsramme: Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Health status and health-related quality of life using the EuroQol 5 Dimension-5 Levels instrument.
Baseline through treatment and protocol-specified follow-up; up to approximately 3 years or more
Time to Deterioration
Tidsramme: From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more
Time to protocol-defined deterioration in disease-related symptoms and health-related quality of life; detailed definition will be specified in the Statistical Analysis Plan.
From baseline/randomization through protocol-defined deterioration; up to approximately 3 years or more

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pharmacokinetic Evaluation - Cmax
Tidsramme: Up to Cycle 9 (each cycle is 28 days)
Peak plasma concentration of VT3989
Up to Cycle 9 (each cycle is 28 days)
Pharmacokinetic Evaluation - AUC
Tidsramme: Up to Cycle 9 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
Up to Cycle 9 (each cycle is 28 days)
Correlation between VT3989 exposure
Tidsramme: Up to Cycle 9 (each cycle is 28 days)
Correlation between VT3989 exposure
Up to Cycle 9 (each cycle is 28 days)

Samarbeidspartnere og etterforskere

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Sponsor

Vivace Therapeutics, Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. januar 2031

Datoer for studieregistrering

Først innsendt

1. september 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VT3989-003

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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