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ML-016 in Advanced Cancer With Lung and/or Liver Involvement

NCT07723482 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-07-23

No results posted yet for this study

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).

Conditions

  • Advanced Solid Tumor With Lung and/or Liver Involvement

Interventions

DRUG

ML-016

a pH-sensitive polymeric doxorubicin formulated in a nanoporous silicon microparticle

Sponsors & Collaborators

  • Southern Star Research

    collaborator INDUSTRY

  • BrYet US, Inc.

    lead INDUSTRY

Principal Investigators

  • Brenton Seidl, MBBS, BSc, FRACP · Cancer Care Foundation Ltd, Sunshine Coast Haematology and Oncology Clinic

  • Apostolia Tsimberidou, MD, PhD, FASCO, FAAAS · BrYet US, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2030-08-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723482 on ClinicalTrials.gov