CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC

BioAtla

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Biological: PD-1 inhibitor; Biological: CAB-AXL-ADC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04681131

BA3011-002

Details and patient eligibility

About

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

Full 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).

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have measurable disease.
• Age ≥ 18 years
• Adequate renal function
• Adequate liver function
• Adequate hematological function
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least three months.

Exclusion criteria

• Patients must not have clinically significant cardiac disease.
• Patients must not have known non-controlled CNS metastasis.
• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
• Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
• Patients must not have had major surgery within 4 weeks before first BA3011
• Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
• Patients must not be women who are pregnant or breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

CAB-AXL-ADC (BA3011)

Experimental group

Description:

CAB-AXL-ADC (BA3011) alone

Treatment:

Biological: CAB-AXL-ADC

CAB-AXL-ADC (BA3011)+PD-1 inhibitor

Experimental group

Description:

CAB-AXL-ADC (BA3011) with PD-1 inhibitor

Treatment:

Biological: PD-1 inhibitor

Biological: CAB-AXL-ADC