A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRIANA Biomedicines, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TRI-611
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov