IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT07491497 pour CPNPC ALK positif, ALK-Positive Lung Cancer, Cancer du poumon non à petites cellules positif à ALK est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC Phase I, Phase II 160
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07491497 est conçu pour étudier le traitement de CPNPC ALK positif, ALK-Positive Lung Cancer, Cancer du poumon non à petites cellules positif à ALK. Il s'agit d'une étude interventionnel en Phase I Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 11 mars 2026 et vise à recruter 160 participants. Dirigée par TRIANA Biomedicines, Inc., l'étude devrait être terminée d'ici le 30 janvier 2034. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 mars 2026.
Résumé succinct
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...
Afficher plusDescription détaillée
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...
Afficher plusTitre officiel
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
Pathologies
CPNPC ALK positifALK-Positive Lung CancerCancer du poumon non à petites cellules positif à ALKAutres identifiants de l'étude
- TRI-611-101
Numéro NCT
Date de début (réel)
2026-03-11
Dernière mise à jour publiée
2026-03-25
Date de fin (estimée)
2034-01-30
Inscription (estimée)
160
Type d'étude
Interventionnel
PHASE
Phase I
Phase II
Phase II
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
Non randomisé
Modèle d'intervention
Séquentiel
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPart 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 |
ExpérimentalPart 2: Cohort M1 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded | TRI-611 oral ALK molecular glue degrader |
ExpérimentalPart 2: Cohort M2 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required | TRI-611 oral ALK molecular glue degrader |
ExpérimentalPart 2: Cohort M3 Participants without prior ALK TKI treatment | TRI-611 oral ALK molecular glue degrader |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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.Contact central de l'étude
Contact: TRIANA Clinical Trials, [email protected]
5 Centres de l'étude dans 1 pays
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States
Alexander Drilon, MD, Investigateur principal
En recrutement
Ohio
Taylor Cancer Research Center, Maumee, Ohio, 43537, United States
John Nemunaitis, MD, Investigateur principal
En recrutement
Tennessee
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Melissa Johnson, MD, Investigateur principal
En recrutement
Utah
START Mountain Region, West Valley City, Utah, 84119, United States
José Pacheco, MD, Investigateur principal
En recrutement
Virginia
NEXT Virginia, Fairfax, Virginia, 22031, United States
Alexander Spira, MD, Investigateur principal
En recrutement