A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC

Conditions

• ALK-Positive Lung Cancer
• ALK-positive NSCLC
• ALK-positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TRI-611 — DRUG
  oral ALK molecular glue degrader

Study Details

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

Key Dates

Start date

Mar 11, 2026

Status verified

May 2026

Primary completion

May 31, 2029

Completion

Jan 30, 2034

Study Design

Enrollment

160 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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
• Experimental: Part 2: Cohort M1
  Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
• Experimental: Part 2: Cohort M2
  Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
• Experimental: Part 2: Cohort M3
  Participants without prior ALK TKI treatment

Primary Outcome Measure

Part 1: Treatment emergent adverse events [ Time Frame: Within 28 days of the first TRI-611 dose ]

Central Contacts

• TRIANA Clinical Trials
  [email protected]

Locations (7)

Find similar trials in Aurora, CO

Related Studies

• Patient-centered, Optimal Integration of Survivorship and Palliative Care
  Recruiting · Massachusetts General Hospital · Boston, Massachusetts