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CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

Undifferentiated Pleomorphic Sarcoma Clinical Trial

Official title:
A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors

Clinical Trial Summary

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

Clinical Trial Description

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors. Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024). Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03425279
Study type Interventional
Source BioAtla, Inc.
Contact BioAtla Medical Affairs
Phone 858-558-0708
Email medicalaffairs@bioatla.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 15, 2018
Completion date December 2024
View Details
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