Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425279
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2018-01-22
Brief Title:
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Sponsor:
BioAtla Inc
Organization:
BioAtla Inc
Study Overview
Official Title:
A Phase 12 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:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 12 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None