Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | AMT-253 Dose Escalation |
|
| Arm 2 | Experimental | AMT-253 Dose Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT-253 for injection | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Incidence of dose limiting toxicities | 21 days after first dose |
| AEs | Type, incidence and severity of Adverse Events | Up to 24 months |
| SAEs | Type, incidence and severity Serious Adverse Events (SAEs) | Up to 24 months |
| ORR | Overall response rate assessed by the investigator according to RECIST version 1.1 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | aximum concentration (Cmax) | Up to 24 months |
| Tmax | time to peak drug concentration | Up to 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minqi Guan | Contact | 86-15895820062 | minqi.guan@multitudetherapeutics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AUC | Area Under the Curve | Up to 24 months |
| t1/2 | terminal half-life of the ADC, total antibody and free payload | Up to 24 months |
| ADAs | Specification and quantification of anti-drug antibodies | Up to 24 months |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |