Advanced Solid Tumor With Lung and/or Liver InvolvementPhase 1/2NCT07723482
ML-016 in Advanced Cancer With Lung and/or Liver Involvement
A Phase 1/2 study testing ML-016 in people with Advanced Solid Tumor With Lung and/or Liver Involvement, run by BrYet US, Inc. at 3 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor With Lung and/or Liver Involvement
- What is being tested?
- ML-016
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesAustralia
- Study dates
- 25 Sep 2026to Oct 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Hemoglobin ≥8.0 g/dL ,
- Neutrophil count ≥1.5 x 109/L,
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- Platelets ≥75 x 109/L
- The participant has adequate baseline kidney function, as demonstrated by the following:
- Serum creatinine ≤1.5 x ULN, and/or
- Calculated creatinine clearance ≥60 ml/min using the Cockroft-Gault formula or per institutional standard method
- The participant has adequate baseline liver function, as demonstrated by the following:
- Total bilirubin <1.5 x ULN (except for participants with Gilbert syndrome), or
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤3 x ULN, or for participants with liver involvement AST/ALT <5 x ULN
- Measurable disease using RECIST v 1.1 for solid tumors
- Evidence of tumor in the lung and/or liver based on imaging studies.
- For participants with lung metastases, adequate pulmonary function: FEV1, FVC and DLCO ≥50% predicted (corrected for hemoglobin) and no oxygen dependency.
- For participants with liver metastases, adequate liver function with less than 70% liver involvement as measured by imaging (i.e. CT, MRI, PET/CT, or ultrasound).
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Documented to be surgically sterile or postmenopausal (amenorrhea 24 months and follicle-stimulating hormone [FSH] ≥30 mIU/mL), OR
- Practicing true abstinence for at least 28 days prior to study treatment until 120 days after the last dose of study treatment and having a negative serum urine pregnancy test within 72 hours before initiating treatment, OR
- Using 2 forms of highly effective contraception, including 1 physical barrier (condom or diaphragm) plus another method, such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) or nonhormonal methods (eg, intrauterine device, spermicidals) from screening or at least 28 days prior to study treatment administration (whichever is earlier) until 120 days after the last dose of study treatment and having a negative serum urine pregnancy test within 72 hours before initiating treatment.
- Male participants with female partners of childbearing potential may be enrolled if they are:
- Documented to be surgically sterile (vasectomy), OR
- Practicing true abstinence until 28 days after the last dose of study treatment, OR
- Using 2 effective methods of contraception including one barrier method (e.g., condom with spermicide and contraception by female partner) for the duration of time on the study and for 120 days after administration of the last dose of study treatment, unless their partners are infertile or surgically sterile.
- Minimum life expectancy of 3 months.
- Ability to read and understand the informed consent form and willingness and ability to give informed consent and demonstrate comprehension of the trial before undergoing any trial assessments.
- The participant can adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment.
- The participant allows tissue biopsy to be available (archive or fresh tissue) unless approved by the Sponsor.
Who cannot join
- 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
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- 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.
- Previous treatment with total cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (≥450 mg/m2).
- Hypersensitivity to doxorubicin, any of its excipients, or other anthracyclines or anthracenediones or compounds of similar chemical or biologic composition as the study drug.
- The participant has a history of (non-infectious) pneumonitis or interstitial pulmonary disease that required corticosteroids within the past 3 months or has current pneumonitis or interstitial pulmonary disease.
- The participant has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the participant at significant risk for pulmonary complications during the study.
- The participant has an active autoimmune disease that required systemic treatment in the past. Participants who have not required systemic treatment for at least two years may be enrolled if permission is provided after discussion with the Medical Monitor (replacement therapy, e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment, and is allowed).
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring intravenous antibiotics, severe malnutrition, chronic severe liver or renal disease).
- The participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Jubb, Clinical Project Manager, Southern Star Research contact
Matt Wagener, VP Clinical Development Operations, BrYet contact
Australia3 sites, 3 recruiting
- Recruiting
Sunshine Coast Haematology and Oncology Clinic
Buderim, Queensland
Elizabeth Gibson, +61 7 5479 0000, egibson@cancercarefoundation.org.au
Brenton Seidl
- Recruiting
Southside Cancer Care Centre
Miranda, New South Wales
Kareena Young, +61 2 8556 9372, kyoung@cancercarefoundation.org.au
Paul de Souza
- Not yet recruiting
Illawarra Cancer Care Center, Wollongong Hospital
Wollongong, New South Wales
Carly Leighton, +61 2 4253 4384, carly.leighton@health.nsw.gov.au
Udit Nindra
About this study
Official title: Phase 1/2 Study of ML-016 in Participants With Advanced Cancer With Lung and/or Liver Involvement
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).
Read the detailed description
ML-016 will be administered intravenously as a monotherapy to assess safety, tolerability, pharmacokinetics (PK), and anti-tumor activity in participants with advanced/metastatic solid tumors with lung and/or liver involvement. The involvement of the lung and/or liver can involve primary or metastatic disease.
Participants eligible for treatment include those whose disease 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.
Participants will be administered ML-016 on Day 1 of each 21-day cycle. Treatment may continue until the participant's disease worsens or another treatment discontinuation criterion is met.
Phase 1 will be a standard dose escalation design, and Phase 2 will be a dose expansion design evaluating two doses in disease-specific cohorts.
- Being tested
- ML-016
- Keywords
- Solid Tumors, Refractory, Relapsed, Lung metastasis, Liver metastasis, Metastatic, Neoplasms
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML-016Drug
Also called iNPG-pDox
a pH-sensitive polymeric doxorubicin formulated in a nanoporous silicon microparticle
| Study group | Role | What they receive |
|---|---|---|
| ML-016 Monotherapy | Experimental | ML-016 participants will be assigned to dose levels upon entry Receives: Drug: ML-016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) during the DLT assessment period
The incidence of dose-limiting toxicities (DLTs) graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during the DLT assessment period
Measured: Days 1-21 of the first cycle of study treatment (DLT assessment period)
Frequency and severity of adverse events (AEs) and serious AEs (SAEs)
The frequency and severity of adverse events (AEs) and serious AEs (SAEs), treatment discontinuations due to toxicity, and clinical laboratory abnormalities
Measured: 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
Identify the MTD or maximum tested dose and doses recommended for expansion
Measured: Days 1-21 of the first cycle of study treatment (DLT assessment period)
Vital Signs: Blood Pressure
Incidence and severity of changes in blood pressure from baseline
Measured: 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
Incidence and severity of changes in heart rate from baseline
Measured: 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
Incidence and severity of changes in ECG QT Interval from baseline
Measured: 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
Incidence and severity of changes in LVEF from baseline
Measured: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
Secondary outcomes (9)
Disease control rate (DCR)
Disease control rate (DCR) is defined as the percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Measured: At least 42 days after the first dose of investigational product
Overall response rate (ORR)
Overall response rate (ORR) is defined as the percentage of patients who have achieved CR or PR per RECIST 1.1.
Measured: From first dose of study drug through 12 months following first dose
Duration of response (DOR)
Duration of response (DOR) is defined as the time from the date measurement criteria are first met for patients who achieve PR or CR, to the date measurement criteria are first met for PD.
Measured: Time from the date measurement criteria are first met for patients who achieve PR or CR, to the date measurement criteria are first met for PD, assessed up to 12 months.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of initiation of study treatment to the date measurement criteria are first met for PD or death from any cause, whichever occurs first.
Measured: Time from the date of initiation of study treatment to the date measurement criteria are first met for PD or death from any cause, whichever occurs first, assessed up to 12 months.
Time to Progression (TTP)
Time to Progression (TTP) is defined as the time from the date of initiation of study treatment to the date that the measurement criteria are first met for PD.
Measured: Time from the date of initiation of study treatment to the date that the measurement criteria are first met for PD, assessed up to 12 months.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of initiation of study treatment to the date of death from any cause.
Measured: Time from the date of initiation of study treatment to the date of death from any cause, assessed up to 12 months.
Pharmacokinetic Profile: Cmax
Cmax: Maximum peak plasma concentration
Measured: From first dose of study drug through 21 days following the first dose of study treatment (1 cycle)
Pharmacokinetic Profile: AUClast
AUClast: Area under the concentration-time curve from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn
Measured: From first dose of study drug through 21 days following the first dose of study treatment (1 cycle)
Pharmacokinetic Profile: T½
T½: Half-life
Measured: From first dose of study drug through 21 days following the first dose of study treatment (1 cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start25 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor With Lung and/or Liver InvolvementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrYet US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Responsible party
- Sponsor
- Investigators
- Brenton Seidl, MBBS, BSc, FRACP, Principal investigator, Cancer Care Foundation Ltd, Sunshine Coast Haematology and Oncology ClinicApostolia Tsimberidou, MD, PhD, FASCO, FAAAS, Study director, BrYet US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723482
- Sponsor's protocol ID
- BP-ML-016-01
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of ML-016 in Participants With Advanced Cancer With Lung and/or Liver Involvement
- ClinicalTrials.gov ID
- NCT07723482
- Acronym / sponsor ID
- BP-ML-016-01
- Keywords
- Solid Tumors, Refractory, Relapsed, Lung metastasis, Liver metastasis, Metastatic, Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- BrYet US, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
ML-016 will be administered intravenously as a monotherapy to assess safety, tolerability, pharmacokinetics (PK), and anti-tumor activity in participants with advanced/metastatic solid tumors with lung and/or liver involvement. The involvement of the lung and/or liver can involve primary or metastatic disease.
Participants eligible for treatment include those whose disease 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.
Participants will be administered ML-016 on Day 1 of each 21-day cycle. Treatment may continue until the participant's disease worsens or another treatment discontinuation criterion is met.
Phase 1 will be a standard dose escalation design, and Phase 2 will be a dose expansion design evaluating two doses in disease-specific cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ML-016 Monotherapy | Experimental | Drug: ML-016ML-016 participants will be assigned to dose levels upon entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ML-016Also: iNPG-pDoxa pH-sensitive polymeric doxorubicin formulated in a nanoporous silicon microparticle | Drug | ML-016 Monotherapy |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) during the DLT assessment period
Time frame: Days 1-21 of the first cycle of study treatment (DLT assessment period)
The incidence of dose-limiting toxicities (DLTs) graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during the DLT assessment period
Frequency and severity of adverse events (AEs) and serious AEs (SAEs)
Time frame: From first dose of study drug through 30 days following the last dose of study drug
The frequency and severity of adverse events (AEs) and serious AEs (SAEs), treatment discontinuations due to toxicity, and clinical laboratory abnormalities
Maximum tolerated dose (MTD) and doses recommended for expansion
Time frame: Days 1-21 of the first cycle of study treatment (DLT assessment period)
Identify the MTD or maximum tested dose and doses recommended for expansion
Vital Signs: Blood Pressure
Time frame: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
Incidence and severity of changes in blood pressure from baseline
Vital Signs: Heart Rate
Time frame: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
Incidence and severity of changes in heart rate from baseline
Electrocardiograms (ECGs): QT Interval
Time frame: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
Incidence and severity of changes in ECG QT Interval from baseline
Echocardiograms (ECHO): LVEF
Time frame: Baseline and every cycle of study drug (each cycle is 21 days) through 30 days following the last dose of study drug
Incidence and severity of changes in LVEF from baseline
9 secondary outcomes
Disease control rate (DCR)
Time frame: At least 42 days after the first dose of investigational product
Overall response rate (ORR)
Time frame: From first dose of study drug through 12 months following first dose
Duration of response (DOR)
Time frame: Time from the date measurement criteria are first met for patients who achieve PR or CR, to the date measurement criteria are first met for PD, assessed up to 12 months.
Progression-free survival (PFS)
Time frame: Time from the date of initiation of study treatment to the date measurement criteria are first met for PD or death from any cause, whichever occurs first, assessed up to 12 months.
Time to Progression (TTP)
Time frame: Time from the date of initiation of study treatment to the date that the measurement criteria are first met for PD, assessed up to 12 months.
Overall Survival (OS)
Time frame: Time from the date of initiation of study treatment to the date of death from any cause, assessed up to 12 months.
Pharmacokinetic Profile: Cmax
Time frame: From first dose of study drug through 21 days following the first dose of study treatment (1 cycle)
Pharmacokinetic Profile: AUClast
Time frame: From first dose of study drug through 21 days following the first dose of study treatment (1 cycle)
Pharmacokinetic Profile: T½
Time frame: From first dose of study drug through 21 days following the first dose of study treatment (1 cycle)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Jubb, Clinical Project Manager, Southern Star Research contact
Matt Wagener, VP Clinical Development Operations, BrYet contact
Brenton Seidl, MBBS, BSc, FRACP principal investigator
Cancer Care Foundation Ltd, Sunshine Coast Haematology and Oncology Clinic
Apostolia Tsimberidou, MD, PhD, FASCO, FAAAS study director
BrYet US, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ML-016 in people with Advanced Solid Tumor With Lung and/or Liver Involvement, run by BrYet US, Inc. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Jubb, Clinical Project Manager, Southern Star Research (+61 (0)2 9011 6266, ajubb@southernstarresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) during the DLT assessment period (time frame: Days 1-21 of the first cycle of study treatment (DLT assessment period)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.