Actively Recruiting
Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors
Led by Multitude Therapeutics Inc. · Updated on 2025-09-05
96
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AMT-253, an investigational drug, in patients with unresectable or metastatic malignant melanoma and other advanced solid tumors. This is a non-randomized, open-label, multicenter study that includes both Phase I dose escalation and Phase II dose expansion. The study is sponsored by Multitude Therapeutics Inc. and aims to assess safety and response in this patient group. The study involves two treatment arms: dose escalation and dose expansion of AMT-253, which is given intravenously. Participants receive this experimental drug according to the assigned dose level or expansion cohort. The study includes both early and later phase components to determine appropriate dosing and evaluate treatment effects over time. Participants will be monitored closely with evaluations including assessment of dose-limiting toxicities during the first 21 days, adverse events, serious adverse events, and overall response rate for up to 24 months. Blood levels of the drug and immune responses will also be measured. Tumor tissue samples are collected at screening, and participants are followed for safety and effectiveness outcomes through scheduled visits during and after treatment.
CONDITIONS
Brief 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 the study schedule.
- Patients with confirmed melanoma or other advanced solid tumors.
- Patients must have had at least one systemic therapy with progressive disease during or after the last treatment.
- At least one measurable lesion as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of at least 3 months.
- 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 prior to first dose.
- Male patients must agree to use a latex condom during and for 12 weeks after treatment.
- Male patients must agree not to donate sperm, and female patients must agree not to donate eggs during and for 12 weeks after treatment.
- 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 metastases.
- Active or chronic skin disorders requiring systemic therapy.
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Persistent toxicities from previous anti-cancer treatments above Grade 1.
- Recent systemic anti-cancer therapy within five half-lives or 21 days prior to first dose.
- Major surgery within 28 days prior to first dose or incomplete recovery from surgery.
- Significant cardiac disease such as recent heart attack, congestive heart failure, uncontrolled blood pressure or arrhythmias.
- History of thromboembolic or cerebrovascular events within six months prior to first dose.
- Acute or significant infections including hepatitis B, hepatitis C, or HIV.
- Administration of a live vaccine within 28 days prior to first dose of the study drug.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At least 21 days for initial dose-limiting toxicity assessment and ongoing treatment up to 24 months or until discontinuation.
Participants receive AMT-253 administered intravenously as part of dose escalation or dose expansion to treat advanced solid tumors.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
M
Minqi Guan
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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