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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 5, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07723482). This is a study registration, not published results. Lead sponsor: BrYet US, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 108 participants (ESTIMATED). Conditions: Advanced Solid Tumor With Lung and/or Liver Involvement. Interventions: DRUG: ML-016. Primary outcome measures: Incidence of dose-limiting toxicities (DLTs) during the DLT assessment period , Days 1-21 of the first cycle of study treatment (DLT assessment period); Frequency and severity of adverse events (AEs) and serious AEs (SAEs) , From first dose of study drug through 30 days following the last dose of study drug; Maximum tolerated dose (MTD) and doses recommended for expansion , Days 1-21 of the first cycle of study treatment (DLT assessment period); Vital Signs: Blood Pressure , Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug; Vital Signs: Heart Rate , Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug; Electrocardiograms (ECGs): QT Interval , Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug; Echocardiograms (ECHO): LVEF , Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug. Brief summary: This is an open-label, multi-center, phase 1/2 dose-escalation and dose expansion study evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of ML-016 in participants with advanced solid tumors with lung and/or liver involvement (primary or metastatic disease).