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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioAtla, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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