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

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

Detailed Description
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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).

Official Title
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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

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Biological: CAB-AXL-ADC
* Biological: PD-1 inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAB-AXL-ADC (BA3011)<br>CAB-AXL-ADC (BA3011) alone | Biological: CAB-AXL-ADC<br>* Conditionally active biologic anti-AXL antibody drug conjugate<br>* Other names: BA3011;|
| Experimental: CAB-AXL-ADC (BA3011)+PD-1 inhibitor<br>CAB-AXL-ADC (BA3011) with PD-1 inhibitor | Biological: CAB-AXL-ADC<br>* Conditionally active biologic anti-AXL antibody drug conjugate<br>* Other names: BA3011;Biological: PD-1 inhibitor<br>* PD-1 inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Objective Response Rate (ORR) per RECIST v1.1 | Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 | Up to 24 months | 
| Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5 | Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5 | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response (DOR) | Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first | Up to 24 months | 
| Progression-free survival (PFS) | Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to 24 months | 
| Best overall response (BOR) | All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy | Up to 24 months | 
| Disease control rate (DCR) | Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks. | Up to 24 months | 
| Time to response (TTR) | Time from the first dose of investigational product until the first documentation of OR. | Up to 24 months | 
| Overall survival (OS) | Time from the first dose of BA3021 treatment until death due to any cause. | Up to 24 months | 
| Percent change from baseline in target lesion sum of diameters |  | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer