Clinical Trial: NCT07491497
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | TRIANA Biomedicines, Inc. |
| Information Provided By: | TRIANA Biomedicines, Inc. |
| Last Update Posted: | 2026-09-03 |
Study Overview
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 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
Official Title
Conditions
Intervention / Treatment
- Drug: TRI-611
Other Study ID Numbers
- TRI-611-101
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | TRIANA Biomedicines, Inc. |
| Information Provided By: | TRIANA Biomedicines, Inc. |
| Last Update Posted: | 2026-09-03 |
Study Overview
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 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
Official Title
Conditions
Intervention / Treatment
- Drug: TRI-611
Other Study ID Numbers
- TRI-611-101