Clinical Trials /

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

NCT04681131

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04681131

Trial Eligibility

Document

Title

  • Brief Title: CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC
  • 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

Clinical Trial IDs

  • ORG STUDY ID: BA3011-002
  • NCT ID: NCT04681131

Conditions

  • Non-Small-Cell Lung Cancer

Interventions

DrugSynonymsArms
CAB-AXL-ADCBA3011CAB-AXL-ADC (BA3011)
PD-1 inhibitorCAB-AXL-ADC (BA3011)+PD-1 inhibitor

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
CAB-AXL-ADC (BA3011)ExperimentalCAB-AXL-ADC (BA3011) alone
  • CAB-AXL-ADC
CAB-AXL-ADC (BA3011)+PD-1 inhibitorExperimentalCAB-AXL-ADC (BA3011) with PD-1 inhibitor
  • CAB-AXL-ADC
  • PD-1 inhibitor

Eligibility Criteria

        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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed Objective Response Rate (ORR) per RECIST v1.1
Time Frame:Up to 24 months
Safety Issue:
Description:Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BioAtla, Inc.

Trial Keywords

  • Cancer

Last Updated

August 30, 2021