CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
Brief Summary:
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC
Detailed Description:
This is a multi-center, open-label, Phase 2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of BA3011 Alone and in Combination With PD-1 Inhibitor in Adult Patients With Metastatic Non-small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor
Estimated Study Start Date: May 2021
Estimated Primary Completion Date: December 2022
Estimated Study Completion Date: December 2022
Arm:
- Experimental: CAB-AXL-ADC (BA3011)
- Experimental: CAB-AXL-ADC (BA3011)+PD-1 inhibitor
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 240 |
| Estimated Study start date | 01 May 2021 |
| Estimated Study Completion Date | 01 December 2022 |