Actively Recruiting
AMT-253 in Patients With Selected Advanced Solid Tumours
Led by Multitude Therapeutics (Australia) Pty Ltd · Updated on 2025-08-14
54
Participants Needed
7
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
AMT-253 in Patients With Selected Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing and able to sign informed consent and follow study schedule and requirements
- Age 18 years or older at time of consent
- Patients who have had at least one systemic therapy and show progressive disease during or after most recent therapy
- No further standard therapy available or intolerable to standard therapy
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group performance status of 0-1
- Life expectancy of 3 months or more
- Adequate organ function
- Women of childbearing potential must agree to use two effective contraceptive methods during and for 12 weeks after treatment
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Male patients must agree to use latex condom during and for 12 weeks after treatment
- Male and female patients must agree not to donate sperm or eggs during and for 12 weeks after treatment
- Availability of tumor tissue sample at screening
You will not qualify if you...
- Central nervous system metastasis
- Active or chronic skin disorders requiring systemic therapy
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Active eye conditions requiring treatment or close monitoring, including macular degeneration, papilledema, diabetic retinopathy with macular oedema, wet age-related macular degeneration needing injections, or uncontrolled glaucoma
- Persistent toxicities from prior anti-cancer treatments of Grade greater than 1
- Systemic anti-cancer therapy within five half-lives or 21 days before first dose, whichever is shorter
- Radiotherapy to lung field with total dose 20 Gy or more within 6 months, or wide-field radiotherapy within 28 days
- Major surgery within 28 days before first dose or not recovered from surgery side effects
- Significant cardiac disease including recent myocardial infarction, acute coronary syndromes, congestive heart failure class III or IV, uncontrolled hypertension, or arrhythmias
- History or current interstitial lung disease or pneumonitis requiring steroids
- History of thromboembolic or cerebrovascular events within 6 months
- Active bacterial, fungal or viral infection including hepatitis B or C, or HIV
- Live vaccine administration within 28 days before first dose
- Concurrent treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers within 2 weeks before first dose and during treatment
- Active graft versus host disease, immunodeficiency, autoimmune disease requiring systemic steroids over 10 mg prednisone daily within 14 days before first dose
- Known severe allergy or intolerance to monoclonal antibodies or the investigational product
- Participation in another investigational therapeutic clinical trial
- Known active alcohol or drug abuse
- Pregnant or breastfeeding females
- Medical or psychiatric conditions preventing informed consent or protocol compliance
- Prior malignancy other than current diagnosis within 5 years before first dose
- Other protocol defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Blacktown
Sydney, New South Wales, Australia
Actively Recruiting
2
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Actively Recruiting
3
Maquarie University Hospital
Sydney, New South Wales, Australia
Actively Recruiting
4
ICON Cancer Centre
Brisbane, Queensland, Australia
Actively Recruiting
5
Southern Oncology Clinical Research
Adelaide, South Australia, Australia
Actively Recruiting
6
Cabrini Malvern Hospital
Malvern, Victoria, Australia
Actively Recruiting
7
Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
Research Team
J
Jane Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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