Advanced Solid TumorsPhase 1NCT06199908
AMT-562 in Patients With Selected Advanced Solid Tumors
A Phase 1 study testing AMT-562 in people with Advanced Solid Tumors, run by Multitude Therapeutics (Australia) Pty Ltd at 2 sites in Australia.
Trial summary
This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AMT-562
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesAustralia
- Study dates
- 20 May 2024to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- 2. Age ≥18 years (at the time consent is obtained).
- 3. Patients with histologically confirmed unresectable advanced solid tumor.
- 4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
- 5. Patients must have at least one measurable lesion as per RECIST version 1.1.
- 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- 7. Life expectancy ≥ 3 months.
- 8. Patients must have adequate organ function
- 9. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
- 10. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
- 11. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
- 12. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
- 13. Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Who cannot join
- 1. Central nervous system (CNS) metastasis.
- 2. Active or chronic skin disorder requiring systemic therapy.
- 3. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
- 4. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
- 5. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
- 6. Radiotherapy to lung field at a total radiation dose of ≥ 20 Gy within 6 months, wide-field radiotherapy within 28 days.
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- 7. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
- 8. Significant cardiac disease.
- 9. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis t.
- 10. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
- 11. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
- 12. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
- 13. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment.
- 14. Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
- 15. Known or suspected intolerance to the components of the IMP.
- 16. Concurrent participation in another investigational therapeutic clinical trial.
- 17. Patients with known active alcohol or drug abuse.
- 18. Pregnant or breast-feeding females.
- 19. Mental or medical conditions that prevent the patient from giving informed consent or complying with the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the IMP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrolment in this study.
- 20. Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
Cabrini Malvern Hospital
Malvern, Victoria
Prachi Bhave
- Recruiting
Macquarie University Hospital
North Ryde, New South Wales
Dhanusha Sabanathan
About this study
Official title: First-in-Human, Phase 1 Study of AMT-562 in Patients With Advanced Solid Tumors
This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- AMT-562
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-562Drug
Administered AMT-562 for injection intravenously
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | AMT-562 Dose Escalation Receives: Drug: AMT-562 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs
Incidence of dose limiting toxicities
Measured: up to 24 month
AEs
Type, incidence and severity of Adverse Events
Measured: up to 24 month
SAEs
Type, incidence and severity Serious Adverse Events (SAEs)
Measured: up to 24 month
Secondary outcomes (10)
Cmax
Maximum concentration (Cmax)
Measured: up to 24 month
Tmax
time to peak drug concentration
Measured: up to 24 month
AUC
Area Under the Curve
Measured: up to 24 month
t1/2
terminal half-life of the ADC, total antibody and free payload
Measured: up to 24 month
ADAs
Specification and quantification of anti-drug antibodies
Measured: up to 24 month
ORR
Overall response rate assessed by the investigator according to RECIST version 1.1
Measured: up to 24 month
DCR
Disease control rate assessed by the investigator according to RECIST version 1.1
Measured: up to 24 month
PFS
Progression-free survival assessed by the investigator according to RECIST version 1.1
Measured: up to 24 month
TTR
Time to response assessed by the investigator according to RECIST version 1.1
Measured: up to 24 month
DOR
Duration of response assessed by the investigator according to RECIST version 1.1
Measured: up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start20 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multitude Therapeutics (Australia) Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199908
- Sponsor's protocol ID
- AMT-562-01
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Phase 1 Study of AMT-562 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06199908
- Acronym / sponsor ID
- AMT-562-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Multitude Therapeutics (Australia) Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jan 2024 (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 a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AMT-562AMT-562 Dose Escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- 2. Age ≥18 years (at the time consent is obtained).
- 3. Patients with histologically confirmed unresectable advanced solid tumor.
- 4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
- 5. Patients must have at least one measurable lesion as per RECIST version 1.1.
Key exclusion criteria (20 listed)
- 1. Central nervous system (CNS) metastasis.
- 2. Active or chronic skin disorder requiring systemic therapy.
- 3. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
- 4. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
- 5. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
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 |
|---|---|---|
| AMT-562Administered AMT-562 for injection intravenously | Drug | Arm 1 |
Primary outcome
DLTs
Time frame: up to 24 month
Incidence of dose limiting toxicities
AEs
Time frame: up to 24 month
Type, incidence and severity of Adverse Events
SAEs
Time frame: up to 24 month
Type, incidence and severity Serious Adverse Events (SAEs)
10 secondary outcomes
Cmax
Time frame: up to 24 month
Tmax
Time frame: up to 24 month
AUC
Time frame: up to 24 month
t1/2
Time frame: up to 24 month
ADAs
Time frame: up to 24 month
ORR
Time frame: up to 24 month
DCR
Time frame: up to 24 month
PFS
Time frame: up to 24 month
TTR
Time frame: up to 24 month
DOR
Time frame: up to 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMT-562 in people with Advanced Solid Tumors, run by Multitude Therapeutics (Australia) Pty Ltd at 2 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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minqi Guan (86-15895820062, minqi.guan@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLTs (time frame: up to 24 month). The study lists 3 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 26 Jul 2024; AzTrials last refreshed its copy on 3 Nov 2026.