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

Conditions

Advanced ALK-positive NSCLC

Brief summary

1. Overall safety profile as assessed by the type, frequency, severity, timing, and relationship to investigational medicinal product (IMP) of adverse events (AEs), including dose-limiting toxicity (DLT) rate, and changes in vital signs, electrocardiograms (ECGs), and safety laboratory tests, 2. ORR and DofR

Detailed description

1.1 Summary of TRI-611 plasma PK parameters, including half-life (t1/2), AUC, maximum observed plasma concentration (Cmax), and minimum observed plasma concentration (Cmin) after a single and multiple oral doses, 1.2 Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), depth of response (DofR), PFS, overall survival (OS), 1.3 CNS ORR, DOR, time to intracranial progression, 1.4 Profile changes in ALK protein levels in tumor sample on treatment vs at baseline, 2.1 Safety profile as assessed by the type, frequency, severity, timing, and relationship to IMP for AEs, and changes in vital signs, ECGs, and safety laboratory tests, 2.2 DOR, DCR, CBR, PFS, OS, 2.3 CNS ORR, DOR, time to intracranial progression

Related papers

No related papers found yet.

Interventions

DRUGTRI-611

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Overall safety profile as assessed by the type, frequency, severity, timing, and relationship to investigational medicinal product (IMP) of adverse events (AEs), including dose-limiting toxicity (DLT) rate, and changes in vital signs, electrocardiograms (ECGs), and safety laboratory tests, 2. ORR and DofR	—

Secondary

Measure	Time frame
1.1 Summary of TRI-611 plasma PK parameters, including half-life (t1/2), AUC, maximum observed plasma concentration (Cmax), and minimum observed plasma concentration (Cmin) after a single and multiple oral doses, 1.2 Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), depth of response (DofR), PFS, overall survival (OS), 1.3 CNS ORR, DOR, time to intracranial progression, 1.4 Profile changes in ALK protein levels in tumor sample on treatment vs at baseline, 2.1 Safety profile as assessed by the type, frequency, severity, timing, and relationship to IMP for AEs, and changes in vital signs, ECGs, and safety laboratory tests, 2.2 DOR, DCR, CBR, PFS, OS, 2.3 CNS ORR, DOR, time to intracranial progression	—

Measure

Time frame

1.1 Summary of TRI-611 plasma PK parameters, including half-life (t1/2), AUC, maximum observed plasma concentration (Cmax), and minimum observed plasma concentration (Cmin) after a single and multiple oral doses, 1.2 Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), depth of response (DofR), PFS, overall survival (OS), 1.3 CNS ORR, DOR, time to intracranial progression, 1.4 Profile changes in ALK protein levels in tumor sample on treatment vs at baseline, 2.1 Safety profile as assessed by the type, frequency, severity, timing, and relationship to IMP for AEs, and changes in vital signs, ECGs, and safety laboratory tests, 2.2 DOR, DCR, CBR, PFS, OS, 2.3 CNS ORR, DOR, time to intracranial progression

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Outcome results

None listed