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

ConditionsALK-positive NSCLCALK-Positive Lung CancerALK-positive Non-small Cell Lung Cancer
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

This trial does not accept healthy volunteers

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 [in US only: '2 or more 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

Design model

Sequential

Treatments tested in this trial

  • TRI-611

    Drug

    oral ALK molecular glue degrader

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Part 1: Dose Escalation and BackfillExperimental treatment 1 intervention
Group B: Part 2: Cohort M1Experimental treatment 1 intervention
Group C: Part 2: Cohort M2Experimental treatment 1 intervention
Group D: Part 2: Cohort M3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Treatment emergent adverse events

Treatment emergent adverse events (TEAEs)

Time frame
Within 28 days of the first TRI-611 dose
2

Part 2: Objective response rate (ORR)

Determine the objective response rate (ORR) based on RECIST v1.1

Time frame
Approximately 16 weeks after the last participant dosed in Part 2
3

Part 2: Depth of response (DofR)

Defined as the greatest percentage reduction in the sum of diameters of target lesions from baseline

Time frame
Approximately 16 weeks after the last participant dosed in Part 2

Secondary outcomes

1

Part 1: Half-life (t1/2) of TRI-611

Determine the t1/2 of TRI-611

Time frame
Pre-dose and up to 24 hours post-dose
2

Part 1: Area under the curve (AUC) of TRI-611

Determine the AUC of TRI-611

Time frame
Pre-dose and up to 24 hours post-dose
3

Part 1: Maximum plasma concentration (Cmax) of TRI-611

Determine the Cmax of TRI-611

Time frame
Pre-dose and up to 24 hours post-dose
4

Part 1: Minimum plasma concentration (Cmin) of TRI-611

Determine the Cmin of TRI-611

Time frame
Pre-dose and up to 24 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TRIANA Biomedicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
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