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History of Changes for Study: NCT03425279
CAB-AXL-ADC Safety and Efficacy Study in Patients With Solid Tumors
Latest version (submitted July 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 6, 2018 None (earliest Version on record)
2 February 15, 2018 Study Status
3 March 6, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 April 19, 2018 Contacts/Locations and Study Status
5 October 4, 2018 Contacts/Locations and Study Status
6 January 22, 2019 Contacts/Locations, Study Status, Eligibility and Conditions
7 March 9, 2019 Contacts/Locations and Study Status
8 April 30, 2019 Study Status and Contacts/Locations
9 June 12, 2020 Contacts/Locations, Study Status, Conditions, Study Identification, Eligibility, Arms and Interventions and Study Description
10 September 7, 2021 Contacts/Locations, Outcome Measures, Arms and Interventions, Eligibility, Study Design, Study Status, Study Identification, Conditions and Study Description
11 July 11, 2022 Study Status, Contacts/Locations and Study Description
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Study NCT03425279
Submitted Date:  February 6, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: BA3011-001
Brief Title: CAB-AXL-ADC Safety and Efficacy Study in Patients With Solid Tumors
Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients With Advanced Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2018
Overall Status: Not yet recruiting
Study Start: February 2018
Primary Completion: January 2020 [Anticipated]
Study Completion: January 2022 [Anticipated]
First Submitted: January 22, 2018
First Submitted that
Met QC Criteria:
February 6, 2018
First Posted: February 7, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
February 6, 2018
Last Update Posted: February 7, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioAtla, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

This study will consist of a dose escalation phase and a dose expansion phase.

Open or close this module Conditions
Conditions: Solid Tumor
Non Small Cell Lung Cancer
Castration-resistant Prostate Cancer
Pancreatic Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BA3011
All patients will receive BA3011, CAB-AXL-ADC.
Biological: CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. Dose Limiting Toxicities (DLTs)
[ Time Frame: DLT will be assessed from first treatment cycle (3 weeks) ]

Number of DLTs
3. Maximum Tolerated Dose (MTD)
[ Time Frame: [Time Frame: MTD will be assessed from first treatment cycle (3 weeks)] ]

Number of DLTs
4. Anti-tumor activity
[ Time Frame: Up to 24 months ]

Overall Response Rate (ORR) according to RECIST version 1.1
Secondary Outcome Measures:
1. Pharmacokinetics: Cmax
[ Time Frame: Up to 24 months ]

Maximum observed concentration of BA3011
2. Pharmacokinetics: AUC
[ Time Frame: Up to 24 months ]

Area under the concentration versus time curve of BA3011
3. Immunogenicity of BA3011
[ Time Frame: Up to 24 months ]

Presence of anti-drug antibodies (ADA)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • For the dose escalation phase: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor and have failed available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
  • Patients must have measurable disease.
  • For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), castration-resistant prostate cancer (CRPC) and pancreatic ductal adenocarcinoma (PDAC)
  • 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 received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011 administration.
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Yong Ben, MD
Telephone: 888-842-9844
Email: yben@bioatla.com
Central Contact Backup: Elizabeth Wieland
Email: ewieland@bioatla.com
Study Officials: Yong Ben
Study Director
BioAtla, Inc.
Locations: United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Contact:Contact: Howard Burris, MD Howard.Burris@SarahCannon.com
Contact:Principal Investigator: Howard Burris, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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