ML-016 in Advanced Cancer With Lung and/or Liver Involvement (NCT07723482) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
ML-016 in Advanced Cancer With Lung and/or Liver Involvement
Australia108 participantsStarted 2026-08
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years old on the day of signing the consent form
. Histopathological or cytological confirmed diagnosis of advanced (locally advanced or metastatic) solid malignancy which is refractory to standard therapeutic options or for which no standard measures with curative intent or likelihood of disease control are available, or such measures are not acceptable to the participant.
. Eastern Cooperative Oncology Group Performance Status ≤1
. The participant has adequate baseline hematologic function, as demonstrated by the following:
. The participant has adequate baseline kidney function, as demonstrated by the following:
. The participant has adequate baseline liver function, as demonstrated by the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs) during the DLT assessment period
Timeframe: Days 1-21 of the first cycle of study treatment (DLT assessment period)
2
Frequency and severity of adverse events (AEs) and serious AEs (SAEs)
Timeframe: From first dose of study drug through 30 days following the last dose of study drug
3
Maximum tolerated dose (MTD) and doses recommended for expansion
Timeframe: Days 1-21 of the first cycle of study treatment (DLT assessment period)
4
Vital Signs: Blood Pressure
Timeframe: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
5
Vital Signs: Heart Rate
Timeframe: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
6
Electrocardiograms (ECGs): QT Interval
Timeframe: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
7
Trial details
NCT IDNCT07723482
SponsorBrYet US, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-08
Contact for this trial
Amanda Jubb, Clinical Project Manager, Southern Star Research
. Measurable disease using RECIST v 1.1 for solid tumors
. Evidence of tumor in the lung and/or liver based on imaging studies.
Exclusion criteria
. Participants must not receive prior anticancer therapy or prior investigational therapy within 3 weeks or 5 half-lives, whatever is shorter, or radiation therapy within 3 weeks, and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed (no palliative radiation may be given to RECIST lesions).
. The participant must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 alopecia and/or neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. Prior toxicities that resulted in laboratory abnormalities should have resolved to Grade ≤1 unless a higher-grade abnormality is allowed by the inclusion criteria. If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.
. Symptomatic brain metastasis or leptomeningeal disease requiring treatment. Participants with treated brain metastasis must have stable disease for at least 4 weeks, as evidenced by brain imaging, and the participant must have been asymptomatic off steroids for at least 2 weeks.
. Cardiac conditions: hypertension (BP \> 160/100) despite optimal therapy, ventricular arrhythmias, significantly impaired cardiac function such as unstable angina pectoris, congestive heart failure with New York Heart Association (NYHA) class III or IV, myocardial infarction within the 6 months prior to trial entry; signs of pericardial effusion, serious arrhythmia (including QTc prolongation of \>470 ms and/or pacemaker), or prior diagnosis of congenital long QT syndrome
. Left ventricular ejection fraction \<50% or below the lower limit of institutional normal (whichever is higher) on screening echocardiogram.
. History of anthracycline induced cardiotoxicity
. History of another primary malignancy (other than basal cell or squamous cell carcinoma, or in situ carcinoma) within 2 years prior to consent.
. Pregnancy or current breastfeeding or planning to breastfeed.
Echocardiograms (ECHO): LVEF
Timeframe: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug