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New treatment option for Malignant Melanoma
Official title AMT-253 in Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT06209580
What this study is testing
What is AMT-253 for injection?
AMT-253 for injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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\. Patients with histologically confirmed melanoma or other advanced solid tumor.
- 3\. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or...
- 4\. Patients must have at least one measurable lesion as per RECIST version 1.1.
- 5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
You likely can't join if
- 1\. Prior treatment with any agent that has the same target.
- 2\. Central nervous system (CNS) metastasis.
- 3\. Active or chronic skin disorder requiring systemic therapy.
- 4\. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
- 5\. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
- 6\. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
See the full eligibility criteria
- 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\. Patients with histologically confirmed melanoma or other advanced solid tumor.
- 3\. 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...
- 4\. Patients must have at least one measurable lesion as per RECIST version 1.1.
- 5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 6\. Life expectancy ≥ 3 months.
- 7\. Patients must have adequate organ function
- 8\. 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 must agree to...
- 9\. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
- 10\. 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.
- 11\. 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.
- 12\. Availability of tumor tissue sample at screening.
- 1\. Prior treatment with any agent that has the same target.
- 2\. Central nervous system (CNS) metastasis.
- 3\. Active or chronic skin disorder requiring systemic therapy.
- 4\. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
- 5\. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
- 6\. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
- 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, such as recent myocardial infarction or acute coronary syndromes, congestive heart failure， uncontrolled hypertension, uncontrolled cardiac arrhythmias.
- 9\. 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.
- 10\. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
- 11\. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.