CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

• ClinicalTrials.gov Identifier: NCT03504488
• Recruitment Status: Recruiting
• First Posted: April 20, 2018
• Last Update Posted: January 31, 2024
• Sponsor: BioAtla, Inc.
• Information provided by (Responsible Party): BioAtla, Inc.

Tracking Information

• First Submitted Date: April 12, 2018
• First Posted Date: April 20, 2018
• Last Update Posted Date: January 31, 2024
• Actual Study Start Date: June 27, 2018
• Estimated Primary Completion Date: December 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2021)

• Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
  Assess dose limiting toxicity as defined in the protocol
• Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
  Assess maximum tolerated dose as defined in the protocol
• Phase 1 and 2: Safety Profile [ Time Frame: Up to 24 months ]
  Frequency and severity of AEs and/or SAEs
• Phase 2: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
  Proportion of patients who achieve a confirmed CR or PR

Original Primary Outcome Measures (submitted: April 12, 2018)

• Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3021) [ 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: 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

Current Secondary Outcome Measures (submitted: September 7, 2021)

• Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
  Plasma concentrations of ADC, total antibody and MMAE
• Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
  Peak Plasma Concentration (Cmax)
• Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
  Area under the plasma concentration versus time curve
• Phase 1: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
  Proportion of patients who achieve a confirmed CR or PR
• Phase 1: Immunogenicity [ Time Frame: Up to 24 months ]
  The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
• Phase 1 and 2: 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
• Phase 1 and 2: 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
• Phase 1 and 2: 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
• Phase 1 and 2: 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
• Phase 1 and 2: Time to response (TTR) [ Time Frame: Up to 24 months ]
  Time from the first dose of investigational product until the first documentation of OR
• Phase 1 and 2: Overall survival (OS) [ Time Frame: Up to 24 months ]
  Time from the first dose of BA3021 treatment until death due to any cause
• Phase 1 and 2: Tumor size [ Time Frame: Up to 24 months ]
  Percent change from baseline in tumor size

Original Secondary Outcome Measures (submitted: April 12, 2018)

• Pharmacokinetics; Cmax [ Time Frame: Up to 24 months ]
  Maximum observed concentration of BA3021
• Pharmacokinetics; AUC [ Time Frame: Up to 24 months ]
  Area under the concentration versus time curve of BA3021
• Immunogenicity of BA3021 [ Time Frame: Up to 24 months ]
  Presence of anti-drug antibodies (ADA)

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

Descriptive Information

• Brief Title: CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
• Official Title: A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)
• Brief Summary: The objective of this study is to assess safety and efficacy of CAB-ROR2-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 BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer
• Melanoma
• Head and Neck Cancer

Intervention

• Biological: CAB-ROR2-ADC
  Conditionally active biologic anti-ROR2 antibody drug conjugate
  Other Name: BA3021
• Biological: PD-1 inhibitor
  PD-1 inhibitor

Study Arms

• Experimental: Monotherapy - CAB-ROR2-ADC (BA3021) alone
  BA3021 alone Q2W dosing regimen
  Intervention: Biological: CAB-ROR2-ADC
• Experimental: Combination Therapy
  CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
  Interventions:

  • Biological: CAB-ROR2-ADC
  • Biological: PD-1 inhibitor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 7, 2021): 420
• Original Estimated Enrollment (submitted: April 12, 2018): 120
• Estimated Study Completion Date: December 30, 2025
• Estimated Primary Completion Date: December 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all 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), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
• 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 a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas 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 BA3021 administration.
• Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
• 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; 8585580708 ext 3333; medicalaffairs@bioatla.com

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

Administrative Information

• NCT Number: NCT03504488
• Other Study ID Numbers: BA3021-001
• 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