En fas 1/2-studie av TRI-611 vid ALK-positiv NSCLC
En fas 1/2-studie med doseskalering och expansion av TRI-611, en oral ALK-molekylär limdegraderare, hos deltagare med avancerad ALK-positiv NSCLC
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 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.
In this study participants will:
- Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing
- Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter
- Keep a diary of each time they take the study medication
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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 in two backfill cohorts.
Following completion of Part 1 of the study, Part 2 of the study will be initiated. The second part of the study is comprised of three cohorts (M1, M2, M3) of participants differentiated based on their previous treatment with ALK TKIs (tyrosine kinase inhibitors). During this part of the study the antitumor activity of TRI-611 will be further explored. See eligibility criteria for more details.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: TRIANA Clinical Trials
- E-post: medical@trianabio.com
Studieorter
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New South Wales
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Sydney, New South Wales, Australien, 2000
- Rekrytering
- Royal North Shore Hospital
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Huvudutredare:
- Malinda Itchins, MD
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Westmead, New South Wales, Australien, 2145
- Rekrytering
- Westmead Hospital
-
Huvudutredare:
- Adnan Nagrial, MD
-
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Victoria
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Melbourne, Victoria, Australien, 3000
- Rekrytering
- Peter MacCallum Cancer Centre
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Huvudutredare:
- Ben Solomon, MD
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Lyon, Frankrike, 69008
- Rekrytering
- Centre Léon Bérard
-
Huvudutredare:
- Aurelie Swalduz, MD
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Villejuif, Frankrike, 94800
- Rekrytering
- Gustave Roussy Institute
-
Huvudutredare:
- Anas Gazzah, MD
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-
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California
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San Francisco, California, Förenta staterna, 94158
- Rekrytering
- UCSF
-
Huvudutredare:
- Collin Blakely, MD
-
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Colorado
-
Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- University of Colorado Cancer Center
-
Huvudutredare:
- Kyle Concannon, MD
-
Kontakt:
- Emily Adam
- Telefonnummer: 303-724-8843
- E-post: emily.adam@cuanschutz.edu
-
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Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Rekrytering
- Massachusetts General Hospital
-
Huvudutredare:
- Jessica Lin, MD
-
Kontakt:
- Jessica Lin, MD
- Telefonnummer: 617-724-4000
- E-post: jjlin1@mgb.org
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Boston, Massachusetts, Förenta staterna, 02215
- Rekrytering
- Dana Farber Cancer Center
-
Huvudutredare:
- Alice Shaw, MD
-
Kontakt:
- Alice Shaw, MD
- Telefonnummer: 877-442-3324
- E-post: dfcitopreferrals@dfci.harvard.edu
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Missouri
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St Louis, Missouri, Förenta staterna, 63130
- Rekrytering
- Washington University Medical Center
-
Huvudutredare:
- Saiama Waqar, MD
-
Kontakt:
- Gina Vellequette
- Telefonnummer: 314-362-0872
- E-post: g.vellequette@wustl.edu
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New York
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New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan-Kettering Cancer Center
-
Huvudutredare:
- Alexander Drilon, MD
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Kontakt:
- Memorial Sloan Kettering Cancer Center
- Telefonnummer: 646-608-3758
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710-2000
- Rekrytering
- Duke University
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Huvudutredare:
- Thomas Stinchcombe, MD
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45221
- Rekrytering
- University of Cincinnati Cancer Center
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Huvudutredare:
- Jennifer Leddon, MD
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Maumee, Ohio, Förenta staterna, 43537
- Rekrytering
- Taylor Cancer Research Center
-
Huvudutredare:
- John Nemunaitis, MD
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Kontakt:
- Stephanie Ambrose
- Telefonnummer: 567-402-4500
- E-post: sambrose@tcrcpt.org
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Rekrytering
- UPMC Hillman Cancer Center
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Huvudutredare:
- Lisa Villaruz, MD
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- SCRI Oncology Partners
-
Huvudutredare:
- Melissa Johnson, MD
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Kontakt:
- AskSarah
- Telefonnummer: 844-482-4814
- E-post: scri.ddureferrals@scri.com
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Texas
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Oncology Consultants Research (P1 Trials)
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Huvudutredare:
- Julio Peguero, MD
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Kontakt:
- Julio Peguero, MD
- Telefonnummer: 713-600-0071
- E-post: jpeguero@oncologyconsultants.com
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Utah
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West Valley City, Utah, Förenta staterna, 84119
- Rekrytering
- START-Mountain Region
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Huvudutredare:
- José Pacheco, MD
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Kontakt:
- HOPE Team
- Telefonnummer: 801-907-4750
- E-post: hopeteam@startresearch.com
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
- Rekrytering
- NEXT Virginia
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Huvudutredare:
- Alexander Spira, MD
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Sutton, Storbritannien, SM2 5PT
- Rekrytering
- The Royal Marsden NHS Foundation
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Huvudutredare:
- Anna Minchom, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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 [in US only: '2 or more 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
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Part 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 |
oral ALK molecular glue degrader |
|
Experimentell: Part 2: Cohort M1
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded |
oral ALK molecular glue degrader |
|
Experimentell: Part 2: Cohort M2
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required |
oral ALK molecular glue degrader |
|
Experimentell: Part 2: Cohort M3
Participants without prior ALK TKI treatment |
oral ALK molecular glue degrader |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Part 1: Treatment emergent adverse events
Tidsram: Within 28 days of the first TRI-611 dose
|
Treatment emergent adverse events (TEAEs) |
Within 28 days of the first TRI-611 dose
|
|
Part 2: Objective response rate (ORR)
Tidsram: Approximately 16 weeks after the last participant dosed in Part 2
|
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)
Tidsram: Approximately 16 weeks after the last participant dosed in Part 2
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Part 1: Half-life (t1/2) of TRI-611
Tidsram: Pre-dose and up to 24 hours post-dose
|
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
Tidsram: Pre-dose and up to 24 hours post-dose
|
Determine the AUC of TRI-611 |
Pre-dose and up to 24 hours post-dose
|
|
Part 1: Maximum plasma concentration (Cmax) of TRI-611
Tidsram: Pre-dose and up to 24 hours post-dose
|
Determine the Cmax of TRI-611 |
Pre-dose and up to 24 hours post-dose
|
|
Part 1: Minimum plasma concentration (Cmin) of TRI-611
Tidsram: Pre-dose and up to 24 hours post-dose
|
Determine the Cmin of TRI-611 |
Pre-dose and up to 24 hours post-dose
|
|
Part 1: ORR
Tidsram: Approximately 16 weeks after the last participant dosed in Part 1
|
Determine the ORR based on RECIST v1.1 |
Approximately 16 weeks after the last participant dosed in Part 1
|
|
Part 1: DofR
Tidsram: Approximately 16 weeks after the last participant dosed in Part 1
|
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)
Tidsram: Approximately 5 years after the last participant is dosed with TRI-611
|
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)
Tidsram: Approximately 16 weeks after the last participant dosed
|
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)
Tidsram: Approximately 9 months after the last participant is dosed
|
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)
Tidsram: Approximately 5 years after the last participant is dosed with TRI-611
|
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)
Tidsram: Approximately 5 years after the last participant is dosed with TRI-611
|
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)
Tidsram: Approximately 16 weeks after the last participant dosed
|
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)
Tidsram: Approximately 5 years after the last participant is dosed with TRI-611
|
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)
Tidsram: Approximately 5 years after the last participant is dosed with TRI-611
|
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
Tidsram: Approximately 14 days after the last dose of participants in Part 1 that have consented to on-treatment biopsies
|
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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- TRI-611-101
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