Trial Radar IA | ||
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Lo studio clinico NCT07491497 per NSCLC ALK-Positivo, ALK-Positive Lung Cancer, Carcinoma polmonare non a piccole cellule positivo all'ALK è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Vista a schede
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC Fase I, Fase II 160
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07491497 è uno studio interventistico di Fase I Fase II volto a esaminare il trattamento per NSCLC ALK-Positivo, ALK-Positive Lung Cancer, Carcinoma polmonare non a piccole cellule positivo all'ALK, attualmente in arruolamento. Avviato il 11 marzo 2026, prevede di arruolare 160 partecipanti. Sotto la guida di TRIANA Biomedicines, Inc., dovrebbe concludersi entro il 30 gennaio 2034. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
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...
Mostra di piùDescrizione dettagliata
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...
Mostra di piùTitolo ufficiale
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
Patologie
NSCLC ALK-PositivoALK-Positive Lung CancerCarcinoma polmonare non a piccole cellule positivo all'ALKAltri ID dello studio
- TRI-611-101
Numero NCT
Data di inizio (effettiva)
2026-03-11
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2034-01-30
Arruolamento (previsto)
160
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Fase II
Stato
In arruolamento
Scopo principale
Trattamento
Allocazione
Non randomizzato
Modello di intervento
Sequenziale
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentalePart 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 |
SperimentalePart 2: Cohort M1 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded | TRI-611 oral ALK molecular glue degrader |
SperimentalePart 2: Cohort M2 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required | TRI-611 oral ALK molecular glue degrader |
SperimentalePart 2: Cohort M3 Participants without prior ALK TKI treatment | TRI-611 oral ALK molecular glue degrader |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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.Contatti principali dello studio
Contatto: TRIANA Clinical Trials, [email protected]
5 Centri dello studio in 1 paesi
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States
Alexander Drilon, MD, Investigatore principale
In arruolamento
Ohio
Taylor Cancer Research Center, Maumee, Ohio, 43537, United States
John Nemunaitis, MD, Investigatore principale
In arruolamento
Tennessee
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Melissa Johnson, MD, Investigatore principale
In arruolamento
Utah
START Mountain Region, West Valley City, Utah, 84119, United States
José Pacheco, MD, Investigatore principale
In arruolamento
Virginia
NEXT Virginia, Fairfax, Virginia, 22031, United States
Alexander Spira, MD, Investigatore principale
In arruolamento