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Also known as AVT32-DRL_PB
AVT32 · 1 trial · 1 indication
AUC0-3w (Cycle 1)
| Arm | Type | Description |
|---|---|---|
| AVT32-DRL_PB | EXPERIMENTAL | AVT32-DRL\_PB will be administered during double blind period and open label period |
| Keytruda | ACTIVE_COMPARATOR | Keytruda will be administered during double blind period |
| Name | Type | Description |
|---|---|---|
| AVT32-DRL_PB | BIOLOGICAL | AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks. |
| Keytruda | BIOLOGICAL | Keytruda at a dose 200 mg administered intravenously every 3 weeks. |
Inclusion Criteria: * Participants (male/female) ≥18 years of age at the time of signing the ICF. * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment. * Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma ...
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AVT32 is an investigational monoclonal antibody being developed by Alvotech for melanoma. It is in Phase 1 clinical development and is designed as a proposed biosimilar candidate referencing Keytruda. It has not been approved by the FDA and remains under clinical study.
AVT32 is being studied in participants with fully resected melanoma. The ongoing Phase 1 trial evaluates pharmacokinetic similarity between AVT32 and Keytruda in this adjuvant setting, where patients have had their melanoma surgically removed. It is investigational and not approved for any use.
AVT32 is developed by Alvotech, which trades on Nasdaq under the ticker ALVO. Alvotech is a biopharmaceutical company focused on the development and manufacture of biosimilar medicines. AVT32 is its investigational monoclonal antibody candidate being studied in melanoma.
AVT32 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program currently has one active, recruiting trial, with no completed trials to date.
AVT32 is being evaluated in the Phase 1 trial NCT07475572, titled a pharmacokinetic similarity study comparing AVT32-DRL_PB with Keytruda in participants with fully resected melanoma. The trial is recruiting, is active controlled, randomized, and double blind, and plans to enroll 120 participants in Ukraine.
Yes, AVT32-DRL_PB is an alternative name for AVT32. Both names refer to the same investigational monoclonal antibody developed by Alvotech. The Phase 1 pharmacokinetic similarity trial in fully resected melanoma uses the AVT32-DRL_PB designation.