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Clinical Trial NCT07491497 for ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC Phase 1, Phase 2 160
Clinical Trial NCT07491497 is designed to study Treatment for ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 11 March 2026, with plans to enroll 160 participants. Led by TRIANA Biomedicines, Inc., it is expected to complete by 30 January 2034. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
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...
Show MoreDetailed Description
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...
Show MoreOfficial Title
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
Conditions
ALK-positive NSCLCALK-Positive Lung CancerALK-positive Non-small Cell Lung CancerOther Study IDs
- TRI-611-101
NCT ID Number
Start Date (Actual)
2026-03-11
Last Update Posted
2026-03-25
Completion Date (Estimated)
2034-01-30
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPart 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 |
ExperimentalPart 2: Cohort M1 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded | TRI-611 oral ALK molecular glue degrader |
ExperimentalPart 2: Cohort M2 Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required | TRI-611 oral ALK molecular glue degrader |
ExperimentalPart 2: Cohort M3 Participants without prior ALK TKI treatment | TRI-611 oral ALK molecular glue degrader |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.Study Central Contact
Contact: TRIANA Clinical Trials, [email protected]
5 Study Locations in 1 Countries
New York
Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States
Alexander Drilon, MD, Principal Investigator
Recruiting
Ohio
Taylor Cancer Research Center, Maumee, Ohio, 43537, United States
John Nemunaitis, MD, Principal Investigator
Recruiting
Tennessee
SCRI Oncology Partners, Nashville, Tennessee, 37203, United States
Melissa Johnson, MD, Principal Investigator
Recruiting
Utah
START Mountain Region, West Valley City, Utah, 84119, United States
José Pacheco, MD, Principal Investigator
Recruiting
Virginia
NEXT Virginia, Fairfax, Virginia, 22031, United States
Alexander Spira, MD, Principal Investigator
Recruiting