ML-016 / BrYet - LARVOL DELTA

ML-016 in Advanced Cancer With Lung and/or Liver Involvement (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: BrYet US, Inc.

New P1/2 trial • Lung Cancer • Oncology • Solid Tumor

ML-016: A silicon "plateloid"-based phenotype targeting platform for lung and liver malignancies (AACR 2026) - "The treatment of metastatic and drug-resistant tumors in the lungs and liver remains a major challenge for conventional chemotherapeutic agents, including doxorubicin. ML-016 has recently received Phase I/II Human Research Ethics Committee (HREC) approval in Australia, marking the initiation of first-in-human evaluation. Overall, ML-016 represents an innovative application of silicon plateloid technology that coordinates vascular, microenvironmental, and intracellular mechanisms to enable efficient phenotype-targeted therapy for resistant tumors in the lung and liver, supporting its continued development toward multi-cancer clinical validation."

First-in-human • Breast Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer

BrYet US, Inc. Files IND Application for ML-016, Lead Oncology Therapeutic for Advanced Solid Tumors with Lung and/or Liver Metastases (PharmiWeb) - "Upon approval, the IND will support the expansion of BrYet's ML-016 clinical program with additional trials in the United States."

IND • Oncology • Solid Tumor

BrYet US, Inc. Receives Approval to Initiate in Australia a First-in-Human Phase 1/2 Trial of ML-016 in Advanced Cancers with Lung and/or Liver Involvement (ACCESS Newswire) - "The open-label, dose-escalation and expansion study...is authorized to commence in Australia with the University of the Sunshine Coast (UniSC) Clinical Trials as the lead site. BrYet expects the trial enrollment to begin in early 2026."

New P1/2 trial • Solid Tumor