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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504488
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
BioAtla, Inc.

Study Description
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Brief Summary:
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Triple Negative Breast Cancer Melanoma Head and Neck Cancer Biological: CAB-ROR2-ADC Biological: PD-1 inhibitor Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Monotherapy - CAB-ROR2-ADC (BA3021) alone
BA3021 alone Q2W dosing regimen
 Biological: CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Other Name: BA3021
Experimental: Combination Therapy
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
 Biological: CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Other Name: BA3021

Biological: PD-1 inhibitor
PD-1 inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
    Assess dose limiting toxicity as defined in the protocol

  2. Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
    Assess maximum tolerated dose as defined in the protocol

  3. Phase 1 and 2: Safety Profile [ Time Frame: Up to 24 months ]
    Frequency and severity of AEs and/or SAEs

  4. Phase 2: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
    Proportion of patients who achieve a confirmed CR or PR


Secondary Outcome Measures :
  1. Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Plasma concentrations of ADC, total antibody and MMAE

  2. Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Peak Plasma Concentration (Cmax)

  3. Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Area under the plasma concentration versus time curve

  4. Phase 1: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
    Proportion of patients who achieve a confirmed CR or PR

  5. Phase 1: Immunogenicity [ Time Frame: Up to 24 months ]
    The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Phase 1 and 2: Tumor size [ Time Frame: Up to 24 months ]
    Percent change from baseline in tumor size


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504488


Contacts
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Contact: BioAtla Medical Affairs 8585580708 ext 3333 medicalaffairs@bioatla.com

Locations
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Sponsors and Collaborators
BioAtla, Inc.
More Information
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Responsible Party: BioAtla, Inc.
ClinicalTrials.gov Identifier: NCT03504488    
Other Study ID Numbers: BA3021-001
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Head and Neck Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Skin Neoplasms
Skin Diseases
Breast Neoplasms
Breast Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents