Actively Recruiting
AMT-253 in Patients With Advanced Solid Tumours
Led by Multitude Therapeutics Inc. · Updated on 2025-09-05
96
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.
CONDITIONS
Official Title
AMT-253 in Patients With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be willing and able to understand and sign the informed consent form and follow study visits and requirements
- Histologically confirmed melanoma or other advanced solid tumor
- Patients have had at least one systemic therapy and show progressive disease after most recent therapy, with no further standard options or intolerance to standard therapy
- At least one measurable lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or longer
- Adequate organ function
- Women of childbearing potential must agree to use two effective contraceptive methods during treatment and for 12 weeks after last dose
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Male patients must use latex condoms during treatment and for 12 weeks after last dose, even after vasectomy
- Male patients must agree not to donate sperm and female patients must agree not to donate eggs during treatment and for 12 weeks after last dose
- Availability of tumor tissue sample at screening
You will not qualify if you...
- Prior treatment with any agent targeting the same mechanism
- Central nervous system metastasis
- Active or chronic skin disorder requiring systemic therapy
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Persistent toxicities greater than Grade 1 from previous systemic cancer treatments
- Systemic anti-cancer therapy within five half-lives or 21 days before first dose of study drug
- Major surgery within 28 days before first dose or incomplete recovery from surgery side effects
- Significant cardiac disease such as recent heart attack, acute coronary syndrome, congestive heart failure, uncontrolled high blood pressure, or irregular heart rhythms
- History of blood clots or strokes within six months before first dose
- Acute or significant bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or HIV
- Received a live vaccine within 28 days before first dose of study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
M
Minqi Guan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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