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Advanced Solid TumorPhase 1NCT05906862

AMT-253 in Patients With Selected Advanced Solid Tumours

A Phase 1 study testing AMT-253 in people with Advanced Solid Tumor, run by Multitude Therapeutics (Australia) Pty Ltd at 7 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-253, 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 Tumor
What is being tested?
AMT-253
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
7 sitesAustralia
Study dates
6 Nov 2023to 30 Dec 2026
Phase
Phase 1
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

  • Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
  • Age ≥18 years (at the time consent is obtained).
  • Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
  • Patients must have at least one measurable lesion as per RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥ 3 months.
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  • Patients must have adequate organ function.
  • 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 (examples include oral, parenteral, or implantable hormonal contraceptive, intra-uterine device, barrier contraceptive with spermicide, partner's latex condom or vasectomy) while on study treatment and for at least twelve weeks after the last dose of the IMP.
  • WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
  • 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.
  • 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.
  • Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Who cannot join

  • Central nervous system (CNS) metastasis.
  • Active or chronic skin disorder requiring systemic therapy.
  • History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
  • Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
  • Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
  • Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
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  • Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.
  • Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
  • Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.).
  • 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.
  • Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
  • Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
  • Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A4 or CYP1A2) within 2 weeks prior to the first dose and during the study treatment.
  • Patient who has active graft versus host disease, or diagnosis of immunodeficiency, or has an active autoimmune disease or other conditions that require systemic steroid therapy, i.e. > 10 mg daily prednisone equivalents within 14 days prior to the administration of the first dose; the use of short-course systemic corticosteroids (≤ 7 days) is permitted, with a wash-out period of 1 week prior to the administration of the first dose of the IMP.
  • Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
  • Known or suspected intolerance to the components of the IMP.
  • Concurrent participation in another investigational therapeutic clinical trial.
  • Patients with known active alcohol or drug abuse.
  • Pregnant or breast-feeding females.
  • 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.
  • Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.
  • Note: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jane Zhu contact

13917933915

juanjuan.zhu@multitudetherapeutics.com

7 sites in 1 country

Australia7 sites, 7 recruiting

  • Southern Oncology Clinical Research

    Adelaide, South Australia

    Ganessan Kichenadasse

    Recruiting

  • ICON Cancer Centre

    Brisbane, Queensland

    Jermaine Coward

    Recruiting

  • Cabrini Malvern Hospital

    Malvern, Victoria

    Richardson Gary, 61 03 9508 9542

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, VIC 3004

    Mark Voskoboynik

    Recruiting

  • Blacktown

    Sydney, New South Wales

    Gao Bo

    Recruiting

  • Chris O'Brien Lifehouse

    Sydney, New South Wales

    Steven Kao, 61 02 8514 0140

    Recruiting

  • Maquarie University Hospital

    Sydney, New South Wales

    John Park

    Recruiting

Other trials in Australia

About this study

Official title: First-in-Human, Phase 1 Study of AMT-253, in Patients With Advanced Solid Tumors

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-253, in Patients with Advanced Solid Tumors

Being tested
AMT-253

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMT-253Drug

    Administered intravenously

Study groups in NCT05906862
Study groupRoleWhat they receive
AMT-253 Dose EscalationExperimentalNot described
Receives: Drug: AMT-253

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D)

    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

    Measured: Up to 24 months

  2. Maximum Tolerated Dose (MTD)

    The MTD will be determined using DLTs

    Measured: Up to 24 months

  3. Type, incidence and severity of Adverse Events

    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0

    Measured: Up to 24 months

Secondary outcomes (8)

  1. Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Proportion of patients achieving Complete Response (CR) or Partial Response (PR)

    Measured: Up to 24 months

  2. Disease Control Rate (DCR) according to the RECIST v1.1

    Proportion of patients achieving CR, PR or Stable Disease (SD)

    Measured: Up to 24 months

  3. Progression-free Survival (PFS)

    Time from date of start of treatment to date of the first progression or death, whichever occurs first.

    Measured: Up to 24 months

  4. Concentration of anti-drug antibodies (ADA)

    Immunogenicity profile characterized by concentration of ADAs

    Measured: Up to 24 months

  5. Maximum observed concentration (C[max])

    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-253

    Measured: Up to 24 months

  6. Area under the curve (AUC)

    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-253

    Measured: Up to 24 months

  7. Terminal half-life (t[1/2])

    Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-253

    Measured: Up to 24 months

  8. Time to maximum concentration (Tmax)

    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-253

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start6 Nov 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05906862
Sponsor's protocol ID
AMT-253-01
Status last verified
Aug 2025
First submitted
7 Jun 2023
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMT-253 in people with Advanced Solid Tumor, run by Multitude Therapeutics (Australia) Pty Ltd at 7 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 12 inclusion and 23 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

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 Jane Zhu (13917933915, juanjuan.zhu@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) (time frame: Up to 24 months). 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?

On the ClinicalTrials.gov record for NCT05906862.

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 14 Aug 2025.

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