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Die klinische Studie NCT07491497 für ALK-positives NSCLC, ALK-Positive Lung Cancer, ALK-positiver nicht-kleinzelliger Lungenkrebs ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC Phase 1, Phase 2 160
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Die klinische Studie NCT07491497 untersucht Behandlung im Zusammenhang mit ALK-positives NSCLC, ALK-Positive Lung Cancer, ALK-positiver nicht-kleinzelliger Lungenkrebs. Diese interventionsstudie der Phase 1 Phase 2 hat den Status offene rekrutierung und startete am 11. März 2026. Es ist geplant, 160 Teilnehmer aufzunehmen. Durchgeführt von TRIANA Biomedicines, Inc. wird der Abschluss für 30. Januar 2034 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 25. März 2026 aktualisiert.
Kurzbeschreibung
The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.
The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 wo...
Mehr anzeigenAusführliche Beschreibung
This is a Phase 1/2 dose escalation and dose expansion study designed to evaluate the safety and tolerability of TRI-611, identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in participants with ALK-positive NSCLC.
Part 1 of the study consists of a dose escalation to determine the MTD and/or recommended dose(s) of TRI-611 for further exploration i...
Mehr anzeigenOffizieller Titel
A Phase 1/2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC
Erkrankungen
ALK-positives NSCLCALK-Positive Lung CancerALK-positiver nicht-kleinzelliger LungenkrebsWeitere Studien-IDs
- TRI-611-101
NCT-Nummer
Studienbeginn (tatsächlich)
2026-03-11
Zuletzt aktualisiert
2026-03-25
Studienende (vorauss.)
2034-01-30
Geplante Rekrutierung
160
Studientyp
Interventionsstudie
PHASE
Phase 1
Phase 2
Phase 2
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Sequentiell
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellPart 1: Dose Escalation and Backfill Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line | TRI-611 oral ALK molecular glue degrader |
ExperimentellPart 2: Cohort M1 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded | TRI-611 oral ALK molecular glue degrader |
ExperimentellPart 2: Cohort M2 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required | TRI-611 oral ALK molecular glue degrader |
ExperimentellPart 2: Cohort M3 Participants without prior ALK TKI treatment | TRI-611 oral ALK molecular glue degrader |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Part 1: Treatment emergent adverse events | Treatment emergent adverse events (TEAEs) | Within 28 days of the first TRI-611 dose |
Part 2: Objective response rate (ORR) | Determine the objective response rate (ORR) based on RECIST v1.1 | Approximately 16 weeks after the last participant dosed in Part 2 |
Part 2: Depth of response (DofR) | Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline | Approximately 16 weeks after the last participant dosed in Part 2 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Part 1: Half-life (t1/2) of TRI-611 | Determine the t1/2 of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: Area under the curve (AUC) of TRI-611 | Determine the AUC of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: Maximum plasma concentration (Cmax) of TRI-611 | Determine the Cmax of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: Minimum plasma concentration (Cmin) of TRI-611 | Determine the Cmin of TRI-611 | Pre-dose and up to 24 hours post-dose |
Part 1: ORR | Determine the ORR based on RECIST v1.1 | Approximately 16 weeks after the last participant dosed in Part 1 |
Part 1: DofR | Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline | Approximately 16 weeks after the last participant dosed in Part 1 |
Parts 1&2: Duration of response (DOR) | Determine the DOR based on RECIST v1.1 | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Disease control rate (DCR) | Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 | Approximately 16 weeks after the last participant dosed |
Parts 1&2: Clinical Benefit Rate (CBR) | Defined as the number and percentage of participants who have achieved a response or stable disease based on RECIST v1.1 maintained for a minimum of 6 months | Approximately 9 months after the last participant is dosed |
Parts 1&2: Progression-free survival (PFS) | Determine PFS based on RECIST v1.1 | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Overall survival (OS) | Determine OS based on RECIST v1.1 | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Central Nervous System (CNS) objective response rate (ORR) | Determine CNS ORR based on modified RECIST (mRECIST v1.1) in participants with CNS metastasis at baseline | Approximately 16 weeks after the last participant dosed |
Parts 1&2: CNS duration of response (DOR) | Determine CNS DOR based on mRECIST v1.1 in participants with CNS metastasis at baseline | Approximately 5 years after the last participant is dosed with TRI-611 |
Parts 1&2: Time to intracranial progression (TTP) | Defined as the time to the date of the first documentation of objective progression of intracranial disease | Approximately 5 years after the last participant is dosed with TRI-611 |
Part 1: Profile changes in tumor ALK-fusion protein levels | Assessing treatment-induced modulation of ALK expression only in participants consenting to on-treatment biopsies | Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)
- Measurable disease per RECIST v1.1
- Adequate bone marrow reserve and organ function
- Part 1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
- Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded
- Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line
- Part 2 Cohort M3: participants without prior ALK TKI treatment
- Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs
- For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease
- Ongoing treatment with another anticancer treatment or investigational agent
- Known allergy/hypersensitivity to TRI-611 or any of its ingredients
- Major surgery within 4 weeks of receiving the first dose of TRI-611
TRIANA Biomedicines, Inc.Zentrale Studienkontakte
Kontakt: TRIANA Clinical Trials, [email protected]
5 Studienstandorte in 1 Ländern
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States
Alexander Drilon, MD, Hauptprüfer
Offene Rekrutierung
Ohio
Taylor Cancer Research Center, Maumee, Ohio, 43537, United States
John Nemunaitis, MD, Hauptprüfer
Offene Rekrutierung
Tennessee
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Melissa Johnson, MD, Hauptprüfer
Offene Rekrutierung
Utah
START Mountain Region, West Valley City, Utah, 84119, United States
José Pacheco, MD, Hauptprüfer
Offene Rekrutierung
Virginia
NEXT Virginia, Fairfax, Virginia, 22031, United States
Alexander Spira, MD, Hauptprüfer
Offene Rekrutierung