AMT-253 treatment for advanced solid tumors

Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors

This study is testing a new treatment called AMT-253 to see if it can help people with advanced melanoma and other solid tumors who have run out of other treatment options.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Multitude Therapeutics Inc. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06209580 on ClinicalTrials.gov

What this trial studies

This is a non-randomized, open-label, multicenter Phase I/II study evaluating the safety and efficacy of AMT-253 in patients with unresectable or metastatic malignant melanoma and other advanced solid tumors. The study consists of a Phase I dose escalation to determine the optimal dosing and a Phase II dose expansion to further assess the treatment's effectiveness. Participants must have experienced disease progression after at least one prior systemic therapy and have no available standard treatment options.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed malignant melanoma or other advanced solid tumors who have experienced disease progression after previous therapies.

Not a fit: Patients who have not undergone any prior systemic therapy or those with resectable tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While there have been various studies on treatments for advanced solid tumors, the specific approach of AMT-253 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion 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 therapy is available, or who are intolerable to standard therapy.
* 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 use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Minqi Guan

Conditions Malignant Melanoma; Advanced Solid Tumors