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

• ClinicalTrials.gov Identifier: NCT04681131
• Recruitment Status: Recruiting
• First Posted: December 23, 2020
• Last Update Posted: January 31, 2024
• Sponsor: BioAtla, Inc.
• Information provided by (Responsible Party): BioAtla, Inc.

Tracking Information

• First Submitted Date: December 8, 2020
• First Posted Date: December 23, 2020
• Last Update Posted Date: January 31, 2024
• Actual Study Start Date: March 17, 2021
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2023)

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

Original Primary Outcome Measures (submitted: December 18, 2020)

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

Current Secondary Outcome Measures (submitted: August 23, 2023)

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

Original Secondary Outcome Measures (submitted: December 18, 2020)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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, EGFR, or ALK Inhibitor.
• 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Small-Cell Lung Cancer

Intervention

• Biological: CAB-AXL-ADC
  Conditionally active biologic anti-AXL antibody drug conjugate
  Other Name: BA3011
• Biological: PD-1 inhibitor
  PD-1 inhibitor

Study Arms

• Experimental: CAB-AXL-ADC (BA3011)
  CAB-AXL-ADC (BA3011) alone
  Intervention: Biological: CAB-AXL-ADC
• Experimental: CAB-AXL-ADC (BA3011)+PD-1 inhibitor
  CAB-AXL-ADC (BA3011) with PD-1 inhibitor
  Interventions:

  • Biological: CAB-AXL-ADC
  • Biological: PD-1 inhibitor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 18, 2020): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2025
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BioAtla Medical Affairs; 858-558-0708 ext 3333; medicalaffairs@bioatla.com

• Listed Location Countries: Germany, Greece, Hong Kong, Italy, Poland, Spain, Taiwan, United States

Administrative Information

• NCT Number: NCT04681131
• Other Study ID Numbers: BA3011-002
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: BioAtla, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: BioAtla, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: BioAtla, Inc.
• Verification Date: January 2024