TRI-611 for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the safest dose and evaluate the effectiveness of a new drug, TRI-611, for individuals with ALK-positive non-small cell lung cancer (NSCLC). The first part will test different doses, followed by an assessment of TRI-611's performance in groups based on previous treatments. Ideal candidates have NSCLC with a specific gene change (ALK-positive) and have undergone certain prior treatments. Participants will take TRI-611 regularly, visit the clinic several times in the initial months, and maintain a dose diary. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop any ongoing treatment with another anticancer treatment or investigational agent before participating.
Is there any evidence suggesting that TRI-611 is likely to be safe for humans?
Research has shown that TRI-611 is being tested in individuals with ALK-positive non-small cell lung cancer (NSCLC). The FDA has granted this treatment Fast Track status, often indicating promising early results. Researchers are currently assessing TRI-611 for safety and tolerability, closely monitoring for any side effects or adverse reactions.
As the trial remains in the early stages (Phase 1/2), the primary goals are to determine the correct dosage and assess how well participants tolerate TRI-611. Although detailed information on side effects is not yet available, the progression of TRI-611 in these trials suggests it has passed initial safety evaluations. Ongoing trials are crucial to fully understand its safety, and participants will receive close monitoring throughout the study to ensure their well-being.12345Why do researchers think this study treatment might be promising?
Researchers are excited about TRI-611 for treating non-small cell lung cancer because it offers a unique approach compared to current standards like ALK TKIs, including crizotinib and alectinib. Most treatments target the ALK gene mutations, but TRI-611 is designed to work even after patients have developed resistance to multiple ALK inhibitors, including lorlatinib. This new drug aims to provide an option for patients who have exhausted other targeted therapies, potentially improving outcomes for those with limited alternatives.
What evidence suggests that TRI-611 might be an effective treatment for ALK-positive non-small cell lung cancer?
Studies have shown that TRI-611 is a pill designed to target and break down specific proteins involved in ALK-positive non-small cell lung cancer (NSCLC). This drug can reach the brain, which is crucial for treating cancer that has spread there. Early tests in lab models demonstrated that TRI-611 can combat ALK-positive cancer cells. In this trial, researchers will assign participants to different treatment arms to evaluate TRI-611's effectiveness in various contexts, including those with prior ALK TKI treatments and those without. The treatment shows promise because it might work even if previous treatments have failed. TRI-611 has received fast-track designation from the FDA, highlighting its potential importance in treating this type of lung cancer.12346
Are You a Good Fit for This Trial?
This trial is for adults with ALK-positive non-small cell lung cancer. Participants must have a confirmed diagnosis, measurable disease, and good organ function. Eligibility depends on their previous treatments for ALK-positive NSCLC.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part 1 of the study consists of a dose escalation to determine the maximum tolerated dose (MTD) and/or recommended dose(s) of TRI-611 for further exploration.
Dose Expansion
Part 2 of the study will explore the antitumor activity of TRI-611 in three cohorts based on prior ALK TKI treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- TRI-611
Trial Overview
The study tests different doses of TRI-611 to find the safest amount and see how well it works against ALK-positive NSCLC. It has two parts: one checks safety and dosing, the other looks at effectiveness in groups based on past treatments.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants without prior ALK TKI treatment
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
Find a Clinic Near You
Who Is Running the Clinical Trial?
TRIANA Biomedicines, Inc.
Lead Sponsor
Citations
1.
pulmonologyadvisor.com
pulmonologyadvisor.com/news/molecular-glue-degrader-tri-611-receives-fda-fast-track-for-alk-nsclc/Molecular Glue Degrader TRI-611 Receives FDA Fast ...
TRI-611 is an oral, brain-penetrant molecular glue degrader designed to selectively eliminate ALK fusion proteins in patients with ALK+ NSCLC.
Find a Research Study
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 ( ...
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
TRIANA Biomedicines' TRI-611 Granted U.S. FDA Fast Track Designation for Treatment of ALK Positive Non-small Cell Lung Cancer. "The Phase 1/2 trial is a ...
4.
targetedonc.com
targetedonc.com/view/fda-grants-fast-track-status-to-alk-degrading-molecular-glue-tri-611FDA Grants Fast Track Status to ALK-Degrading Molecular ...
FDA fast tracks TRI-611, an ALK molecular glue degrader for refractory ALK+ NSCLC. Phase 1/2 trial targets resistance after 2 or more TKIs.
A Study of TRI-611 in People With Non-Small Cell Lung ...
Full 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 ...
6.
cancernetwork.com
cancernetwork.com/view/novel-small-molecule-earns-fda-fast-track-designation-in-alk-nsclcNovel Small Molecule Earns FDA Fast Track Designation ...
Investigators are currently evaluating treatment with TRI-611 among patients with ALK-positive non–small cell lung cancer in a phase 1/2 trial.
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