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A Phase 3 Trial in Advanced Epithelioid Mesothelioma (sTEADfast)

11. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

350

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A - VT3989
VT3989 monotherapy in 28-day cycles until BICR-verified progression, unacceptable toxicity, withdrawal, or another protocol-specified reason.
Arzneimittel: VT3989
• 100 mg orally once daily for 2 weeks on treatment followed by 2 weeks off treatment (2W/2W) in each 4-week cycle
Aktiver 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.
Arzneimittel: gemcitabine
• 1,000 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice
Arzneimittel: Vinorelbine
• 25-30 mg/m2 IV on Days 1 and 8 of each 3-week cycle, or per local prescribing information/institutional practice

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival by BICR
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pharmacokinetic Evaluation - Cmax
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Cycle 9 (each cycle is 28 days)
Correlation between VT3989 exposure
Up to Cycle 9 (each cycle is 28 days)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vivace Therapeutics, Inc

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Dezember 2026

Primärer Abschluss (Geschätzt)

1. Mai 2028

Studienabschluss (Geschätzt)

1. Januar 2031

Studienanmeldedaten

Zuerst eingereicht

1. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. September 2026

Zuerst gepostet (Tatsächlich)

17. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • VT3989-003

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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