CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Solid Tumors

• ClinicalTrials.gov Identifier: NCT03425279
• Recruitment Status: Recruiting
• First Posted: February 7, 2018
• Last Update Posted: June 16, 2020
• Sponsor: BioAtla, Inc.
• Information provided by (Responsible Party): BioAtla, Inc.

Tracking Information

• First Submitted Date: January 22, 2018
• First Posted Date: February 7, 2018
• Last Update Posted Date: June 16, 2020
• Actual Study Start Date: February 15, 2018
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2018)

• Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3011) [ Time Frame: Up to 24 months ]
  Measured by frequency and severity of adverse events
• Dose Limiting Toxicities (DLTs) [ Time Frame: DLT will be assessed from first treatment cycle (3 weeks) ]
  Number of DLTs
• Maximum Tolerated Dose (MTD) [ Time Frame: [Time Frame: MTD will be assessed from first treatment cycle (3 weeks)] ]
  Number of DLTs
• Anti-tumor activity [ Time Frame: Up to 24 months ]
  Overall Response Rate (ORR) according to RECIST version 1.1

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 6, 2018)

• Pharmacokinetics: Cmax [ Time Frame: Up to 24 months ]
  Maximum observed concentration of BA3011
• Pharmacokinetics: AUC [ Time Frame: Up to 24 months ]
  Area under the concentration versus time curve of BA3011
• Immunogenicity of BA3011 [ Time Frame: Up to 24 months ]
  Presence of anti-drug antibodies (ADA)

• Original Secondary Outcome Measures: Same as current
• 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 Adult and Adolescent Patients With Solid Tumors
• Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
• Brief Summary: The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors

Detailed Description

This is a multi-center, open-label, Phase 1/2 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) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with nivolumab in Phase 2.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling).

Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Solid Tumor
• Non Small Cell Lung Cancer
• Pancreatic Cancer
• Melanoma
• Sarcoma
• Sarcoma, Ewing
• Osteosarcoma
• Leiomyosarcoma
• Synovial Sarcoma
• Liposarcoma
• Soft Tissue Sarcoma
• Bone Sarcoma
• Refractory Sarcoma

Intervention

Biological: CAB-AXL-ADC

Conditionally active biologic anti-AXL antibody drug conjugate

Study Arms

Experimental: BA3011

Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with nivolumab.

Intervention: Biological: CAB-AXL-ADC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 6, 2018): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2022
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients must have measurable disease.
• Age ≥ 18 years (Phase 1); Age ≥ 12 years (Phase 2)
• 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 received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011 administration. (Phase 1 only)
• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
• Patients must not have Grade 2 or higher peripheral neuropathy.
• 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: Hazel Buncab, AD, ClinOps; 858-263-1598 ext 8582631598; hbuncab@bioatla.com

Contact: Gerlee Thomas, Head of Regulatory; 858-263-1598; gthomas@bioatla.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03425279
• Other Study ID Numbers: BA3011-001
• Has Data Monitoring Committee: No

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

• Responsible Party: BioAtla, Inc.
• Study Sponsor: BioAtla, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: BioAtla, Inc.
• Verification Date: June 2020