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

January 13, 2025 updated by: BioAtla, Inc.

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)

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

132

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11526
        • HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
      • Piraeus, Greece, 18547
        • Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
      • Thessaloniki, Greece, 54622
        • Bioclinic Thessaloniki, Οncology Department
      • Thessaloniki, Greece, 57001
        • European Interbalkan Medical Center, Οncology Department
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Poland
    • Lodzkie
      • Lodz, Lodzkie, Poland, 93-338
        • Polish Mother's Memorial Hospital-Research Institute
      • Tomaszów Mazowiecki, Lodzkie, Poland, 97-200
        • Beata Głogowska
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-609
        • Institute of Genetics and Immunology GENIM LCC in Lublin
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 08-781
        • Malgorzata Kozlik
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-693
        • MED-Polonia, Sp. z o.o. (LLC)
  • Spain
      • Madrid, Spain, 28041
        • University Hospital 12 de Octubre
      • Madrid, Spain, 28027
        • University Clinic of Navarra - Madrid
    • Andalusia
      • Sevilla, Andalusia, Spain, 41014
        • University Hospital Nuestra Senora de Valme
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Catalonia, Spain, 089003
        • Hospital Del Mar
      • Barcelona, Catalonia, Spain, 08908
        • Anna Ramos Luna
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan
        • Linkou Chang Gung Memorial Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope - Duarte
      • La Jolla, California, United States, 92093
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • Los Angeles, California, United States, 90027
        • California Research Institute
      • Los Angeles, California, United States, 90033
        • USC Norris
      • Orange, California, United States, 92868
        • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • University of California San Francisco
      • Whittier, California, United States, 90603
        • American Institute of Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute at Health ONE
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Florida Cancer Specialists & Research Institute
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists & Research Institute
      • Hollywood, Florida, United States, 33028
        • Memorial Cancer Institute (MCI)
      • Saint Petersburg, Florida, United States, 34474
        • Florida Cancer Specialist - North
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
      • Tampa, Florida, United States, 33612
        • Memorial Sloan-Kettering Cancer Center
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University - Georgia Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Systems
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute, Brownsboro Hospital Campus
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology/Oncology Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Care of Nevada
      • Las Vegas, Nevada, United States, 89169
        • OptumCare Cancer Care
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Health
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Outpatient Cancer Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical University of South Carolina- Hollings Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah - Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Therapy
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
Biological: PD-1 inhibitor
PD-1 inhibitor
Biological: CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Other Names:
  • BA3021
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 Names:
  • BA3021

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Plasma concentrations of ADC, total antibody and MMAE
Up to 24 months
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Peak Plasma Concentration (Cmax)
Up to 24 months
Phase 1: Immunogenicity
Time Frame: Up to 24 months
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
Phase 1 and 2: Tumor size
Time Frame: Up to 24 months
Percent change from baseline in tumor size
Up to 24 months
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Area under the plasma concentration versus time curve
Up to 24 months
Phase 1: Confirmed Objective Response Rate (ORR)
Time Frame: Up to 24 months
Proportion of patients who achieve a confirmed CR or PR
Up to 24 months
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAtla, Inc.

Investigators

  • Study Chair: Eric Sievers, BioAtla, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2018

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA3021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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