TRI-611 / Triana Biomedicines - LARVOL DELTA

A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: TRIANA Biomedicines, Inc.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • ALK

TRIANA Biomedicines Announces First Patient Dosed in a Phase 1/2 Trial Evaluating TRI-611 for the Treatment of ALK Positive Non-small Cell Lung Cancer (Businesswire) - "The Phase 1/2 clinical trial is a global, first-in-human, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TRI-611 in patients with ALK+ NSCLC."

First-in-human • Trial status • Non Small Cell Lung Cancer

TRIANA Biomedicines’ TRI-611 Granted U.S. FDA Fast Track Designation for Treatment of ALK Positive Non-small Cell Lung Cancer (Businesswire) - "The Phase 1/2 trial is a global, first-in-human, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TRI-611 in patients with ALK+ NSCLC. The Phase 1 portion will consist of a dose escalation design, enrolling ALK+ NSCLC patients, who have been previously treated with standard of care ALK tyrosine kinase therapies. The Phase 2 portion will further evaluate and characterize the efficacy and safety of TRI-611 across different patient cohorts."

Fast track • First-in-human • Trial status • Non Small Cell Lung Cancer

TRI-611, a development stage molecular glue degrader of ALK, promotes the degradation of TKI-resistant ALK fusion proteins and leads to regression of ALK TKI-refractory tumors (AACR 2026) - "Finally, we show that TRI-611 leads to the regression of an EML4-ALK mutant primary patient-derived xenograft isolated from a patient that had progressed on prior alectinib and lorlatinib. These data demonstrate the potential of TRI-611 to address a key liability of ALK TKIs that all target the same site on ALK and support the development of TRI-611 in all ALK+ NSCLC patients, including patients with wild-type ALK kinase domain and those with acquired TKI resistance mutations."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CRBN • EML4

TRI-611, a development stage molecular glue degrader of ALK for the treatment of ALK-positive NSCLC including central nervous system metastases (AACR 2026) - "TRI-611 represents the first example of a development stage degrader targeting an oncogenic gene fusion and has the potential to expand the arsenal of meaningful therapeutic options for ALK-positive NSCLC patients. The discovery of TRI-611 additionally broadens the reach of CRBN-modulating MGDs by exploiting a previously undescribed degron."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CRBN • EML4 • NTRK

TRI-611, a selective, CNS-penetrant molecular glue degrader of ALK with anti-tumor activity against preclinical models of ALK-fusion positive non-small cell lung cancer including kinase inhibitor refractory tumors (AACR-NCI-EORTC 2025) - "The distinct binding interface of TRI-611 leads to broad selectivity across the global proteome including closely related kinases such as NTRK1, allowing for sustained high target coverage, including in the CNS, without the off-target liabilities that are associated with TKIs. TRI-611 is currently in IND-enabling studies with the potential to transform the treatment of ALK+ NSCLC and would represent the first clinical stage molecular glue degrader of an oncogenic fusion protein."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • NTRK1