NCT03425279

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: BioAtla, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Undifferentiated Pleomorphic Sarcoma
• Myxofibrosarcoma

Interventions

Type	Name	Description
BIOLOGICAL	CAB-AXL-ADC	Conditionally active biologic anti-AXL antibody drug conjugate
BIOLOGICAL	PD-1 inhibitor	PD-1 inhibitor

Timeline

• Start date: 2018-02-15
• Primary completion: 2025-01-08
• Completion: 2025-01-08
• First posted: 2018-02-07
• Last updated: 2025-09-23

Locations

40 sites across 3 countries: United States, Hong Kong, Taiwan

Regulatory

• FDA-regulated drug study