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Eine Studie zur Bewertung von IPN01194 bei alleiniger Verabreichung bei Erwachsenen mit fortgeschrittenen soliden Tumoren

29. September 2026 aktualisiert von: Ipsen

Eine offene Phase-I/IIa-Studie zur ersten Dosissteigerung und Kohortenerweiterung am Menschen zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik, Pharmakodynamik und Antitumoraktivität des ERK1/2-Inhibitors IPN01194 als Einzelwirkstoff bei erwachsenen Teilnehmern mit fortgeschrittenen soliden Tumoren

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.

The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.

In this study, all participants will receive the study drug, which will be taken by mouth (orally).

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The study consists of two parts, called Phase I and Phase IIa.

Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.

The aim of this "dose escalation" phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.

In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).

Each phase will consist of three periods:

  1. A period to assess eligibility (screening period) that will take up to 28 days.
  2. A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug.
  3. A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.

Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.

If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

36

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

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

Studienorte

  • Frankreich
      • Lyon, Frankreich
        • Centre Léon Bérard - Lyon
      • Paris, Frankreich
        • Paris Saint-Louis
      • Saint-Herblain, Frankreich
        • Institut de Cancerologie de l'Ouest (St-Herblain)
      • Villejuif, Frankreich
        • IGR-Villejuif
  • Spanien
      • Barcelona, Spanien
        • Barcelona - Val D'Hebron
      • Madrid, Spanien
        • Fundacion Jimenez Diaz - Madrid
      • Madrid, Spanien
        • M.D. Anderson Cancer Center Madrid
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90025
        • The Angeles Clinic and Research Institute - California
      • San Diego, California, Vereinigte Staaten, 92037
        • UC San Diego Health System - La Jolla
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06510
        • Yale Cancer Center - New Heaven
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • Sarah Cannon Research Institute (SCRI) - Nashville
    • Virginia
      • Fairfax, Virginia, Vereinigte Staaten, 22031
        • Virginia Cancer Specialist

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria :

  • Participants must be ≥18 years of age
  • Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists.
  • Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm).
  • Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1.
  • Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening
  • Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.

Exclusion Criteria

  • Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications.
  • Any evidence of severe active infection or inflammatory condition.
  • Non-adequate cardiac function
  • Have one or more of study defined ophthalmological findings/conditions
  • Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.
  • Known second malignancy within the last 2 years prior to first dose of study intervention..
  • Major surgery within 28 days prior to first dose of study intervention.
  • Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0).
  • Active brain metastases or leptomeningeal metastases
  • Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days.
  • Live vaccine(s) within 28 days prior to first dose of study intervention
  • Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).
  • Treatment with medications that prolong the QT/QTc interval.
  • Treatment with strong and moderate CYP3A4 inducers
  • Treatment with strong or moderate inhibitors of CYP3A4
  • Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
  • Non-adequate bone marrow function
  • Non-adequate renal function
  • Non-adequate hepatic function
  • Non adequate coagulation function.
  • Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C
  • Sensitivity to IPN01194 or any of its components.

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: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Phase I (Dose Escalation with Backfilling)

Nine dose levels are planned to be tested.
Arzneimittel: IPN01194

IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1).

Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.

Arzneimittel: IPN01194

All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I.

Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision
Experimental: Phase IIa (Cohort Expansion)

Study intervention will be administered at one of two doses of interest determined at the end of Phase I.
Arzneimittel: IPN01194

IPN01194 will be taken orally over a period of 28 days (a "Cycle") at the assigned dose level. The dose limiting toxicity (DLT) observation period consists of the first 28 days of treatment with IPN01194 (Cycle 1).

Participants will receive IPN01194 treatment beyond Cycle 1 until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision.

Arzneimittel: IPN01194

All participants will receive IPN01194 orally for 28-day cycles at one of the two dose levels determined at the end of Phase I.

Participants will receive IPN01194 treatment until treatment is precluded by toxicity, disease progression, or upon participant's request or investigator decision

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phase 1: Prozentsatz der Teilnehmer mit dosislimitierender Toxizität (DLT)
Zeitfenster: Innerhalb von 28 Tagen nach der ersten Dosis
Innerhalb von 28 Tagen nach der ersten Dosis
Phase 1: Prozentsatz der Teilnehmer mit Dosisunterbrechungen und dauerhaften Behandlungsabbrüchen
Zeitfenster: 30 Tage nach der letzten Verabreichung der Studienintervention
30 Tage nach der letzten Verabreichung der Studienintervention
Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs)
Zeitfenster: At 30 days following the last administration of study intervention

An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At 30 days following the last administration of study intervention
Phase 2a: Objective response rate (ORR)
Zeitfenster: At end of treatment (up to approximately 32 months)

Defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator.
At end of treatment (up to approximately 32 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phase 1: Zeit bis zur maximalen beobachteten Arzneimittelkonzentration (Tmax) nach Einzel- und Mehrfachdosen von IPN01194
Zeitfenster: An Tag 1 und Tag 15.
An Tag 1 und Tag 15.
Phase 1: Maximal beobachtete Arzneimittelkonzentration (Cmax) nach Einzel- und Mehrfachdosen von IPN01194
Zeitfenster: An Tag 1 und Tag 15.
An Tag 1 und Tag 15.
Phase 1: Geometrisches mittleres Verhältnis von Cmax von IPN01194 im gefütterten Zustand im Vergleich zum nüchternen Zustand
Zeitfenster: Zwischen Tag -8 und Tag -3 (Fastenperiode) und zwischen Tag -10 und Tag -7 (Nahrungsperiode)
Zwischen Tag -8 und Tag -3 (Fastenperiode) und zwischen Tag -10 und Tag -7 (Nahrungsperiode)
Phase 2a: PFS-Rate nach 4 Monaten
Zeitfenster: Von der Randomisierung bis zu 4 Monaten
Von der Randomisierung bis zu 4 Monaten
Phase 2a: Prozentsatz der Teilnehmer mit TEAEs und TE SAEs
Zeitfenster: Am Ende der Behandlung (bis zu etwa 32 Monaten)
Am Ende der Behandlung (bis zu etwa 32 Monaten)
Phase 2a: Prozentsatz der Teilnehmer mit Dosisunterbrechungen und dauerhaften Behandlungsabbrüchen
Zeitfenster: Am Ende der Behandlung (bis zu etwa 32 Monaten)
Am Ende der Behandlung (bis zu etwa 32 Monaten)
Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194
Zeitfenster: At Day 1 and Day 15.

AUCtau is defined as the concentration of drug over one dosing interval.
At Day 1 and Day 15.
Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state
Zeitfenster: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)

AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state
Zeitfenster: Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)

AUCinf is defined as the concentration of drug extrapolated to infinite time.
Between Day -8 and Day -3 (fasted period) and between Day -10 and Day -7 (fed state period)
Phase 1: Prolongation of corrected QT interval (QTc)
Zeitfenster: Within 28 days of first dose

Prolongation of QTc defined as the upper limit of 90% confidence interval for change from baseline QTc evaluated over Cycle 1 at the highest clinically relevant exposure.
Within 28 days of first dose
Phase 1: Objective response rate (ORR)
Zeitfenster: At end of treatment (up to approximately 32 months)

The ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
At end of treatment (up to approximately 32 months)
Phase 2a: Duration of response (DoR)
Zeitfenster: From randomisation to end of treatment (up to approximately 32 months)

Defined as the percentage of participants with BOR of CR or PR, as determined by investigator per RECIST version 1.1
From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Progression-free survival (PFS)
Zeitfenster: From randomisation to end of treatment (up to approximately 32 months)

PFS is defined as the time from the date of randomisation to the date of the first documented disease progression, as determined by investigator per RECIST version 1.1.
From randomisation to end of treatment (up to approximately 32 months)
Phase 2a: Disease control rate (DCR)
Zeitfenster: At end of treatment (up to approximately 32 months)

DCR is defined as the percentage of participants with BOR of CR, PR or stable disease (SD), as determined by investigator per RECIST version 1.1.
At end of treatment (up to approximately 32 months)

Mitarbeiter und Ermittler

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

Sponsor

Ipsen

Ermittler

  • Studienleiter: Ipsen Medical Director, Ipsen

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 (Tatsächlich)

3. April 2024

Primärer Abschluss (Geschätzt)

20. März 2028

Studienabschluss (Geschätzt)

20. März 2028

Studienanmeldedaten

Zuerst eingereicht

27. Februar 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. März 2024

Zuerst gepostet (Tatsächlich)

12. März 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CLIN-01194-450
  • 2023-506228-10-00 (Andere Kennung: Ipsen)
  • 2023 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

IPD-Sharing-Zeitrahmen

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

IPD-Sharing-Zugriffskriterien

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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