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Non Small Cell Lung CancerPhase 1/2NCT03504488

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

A Phase 1/2 study testing CAB-ROR2-ADC and PD-1 inhibitor in people with Non Small Cell Lung Cancer and Triple Negative Breast Cancer, run by BioAtla, Inc. at 59 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
CAB-ROR2-ADC and PD-1 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
59 sitesin 6 countries
Study dates
27 Jun 2018to 30 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Adequate hematological function
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least three months.

Who cannot join

  • 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.

Trial locations and contacts

59 sites in 6 countries.

59 sites in 6 countries

United States38 sites

  • Augusta University - Georgia Cancer Center

    Augusta, Georgia, 30912

  • University of Colorado

    Aurora, Colorado, 80045

  • Hematology/Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park

    Buffalo, New York, 14263

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina, 29407

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Sarah Cannon Research Institute at Health One

    Denver, Colorado, 80218

  • City of Hope - Duarte

    Duarte, California, 91010

  • Florida Cancer Specialists & Research Institute

    Fleming Island, Florida, 32003

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33916

  • Memorial Cancer Institute (MCI)

    Hollywood, Florida, 33028

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California, San Diego (UCSD) - Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Care of Nevada

    Las Vegas, Nevada, 89169

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89169

  • Baptist Health Systems

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • California Research Institute

    Los Angeles, California, 90027

  • USC Norris

    Los Angeles, California, 90033

  • Norton Cancer Institute, Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California San Francisco

    San Francisco, California, 94158

  • Florida Cancer Specialist - North

    St. Petersburg, Florida, 34474

  • Memorial Sloan-Kettering Cancer Center

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • American Institute of Research

    Whittier, California, 90603

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain6 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital del Mar

    Barcelona, Catalonia, 089003

  • Anna Ramos Luna

    Barcelona, Catalonia, 08908

  • University Clinic of Navarra - Madrid

    Madrid, 28027

  • University Hospital 12 de Octubre

    Madrid, 28041

  • University Hospital Nuestra Senora de Valme

    Seville, Andalusia, 41014

Other trials in Spain

Poland5 sites

  • Polish Mother's Memorial Hospital-Research Institute

    Lodz, Łódź Voivodeship, 93-338

  • Institute of Genetics and Immunology GENIM LCC in Lublin

    Lublin, Lublin Voivodeship, 20-609

  • MED-Polonia, Sp. z o.o. (LLC)

    Poznan, Greater Poland Voivodeship, 60-693

  • Beata Głogowska

    Tomaszów Mazowiecki, Łódź Voivodeship, 97-200

  • Malgorzata Kozlik

    Warsaw, Masovian Voivodeship, 08-781

Other trials in Poland

Greece4 sites

  • HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit

    Athens, 11526

  • Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department

    Piraeus, 18547

  • Bioclinic Thessaloniki, Οncology Department

    Thessaloniki, 54622

  • European Interbalkan Medical Center, Οncology Department

    Thessaloniki, 57001

Other trials in Greece

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • LinKou Chang Gung Memorial Hospital

    Taoyuan City

Other trials in Taiwan

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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)

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

Read the 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.

Being tested
CAB-ROR2-ADC, PD-1 inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Melanoma, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB-ROR2-ADCBiological

    Also called BA3021

    Conditionally active biologic anti-ROR2 antibody drug conjugate

  • PD-1 inhibitorBiological

    PD-1 inhibitor

Study groups in NCT03504488
Study groupRoleWhat they receive
Monotherapy - CAB-ROR2-ADC (BA3021) aloneExperimentalBA3021 alone Q2W dosing regimen
Receives: Biological: CAB-ROR2-ADC
Combination TherapyExperimentalCAB-ROR2-ADC (BA3021) with PD-1 inhibitor
Receives: Biological: CAB-ROR2-ADC; Biological: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Safety Profile

    Assess dose limiting toxicity as defined in the protocol

    Measured: Up to 24 months

  2. Phase 1: Safety Profile

    Assess maximum tolerated dose as defined in the protocol

    Measured: Up to 24 months

  3. Phase 1 and 2: Safety Profile

    Frequency and severity of AEs and/or SAEs

    Measured: Up to 24 months

  4. Phase 2: Confirmed Objective Response Rate (ORR)

    Proportion of patients who achieve a confirmed CR or PR

    Measured: Up to 24 months

Secondary outcomes (12)

  1. Phase 1: Pharmacokinetics

    Plasma concentrations of ADC, total antibody and MMAE

    Measured: Up to 24 months

  2. Phase 1: Pharmacokinetics

    Peak Plasma Concentration (Cmax)

    Measured: Up to 24 months

  3. Phase 1: Pharmacokinetics

    Area under the plasma concentration versus time curve

    Measured: Up to 24 months

  4. Phase 1: Confirmed Objective Response Rate (ORR)

    Proportion of patients who achieve a confirmed CR or PR

    Measured: Up to 24 months

  5. Phase 1: Immunogenicity

    The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)

    Measured: Up to 24 months

  6. Phase 1 and 2: Duration of response (DOR)

    Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first

    Measured: Up to 24 months

  7. Phase 1 and 2: Progression-free survival (PFS)

    Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first

    Measured: Up to 24 months

  8. Phase 1 and 2: Best overall response (OR)

    All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

    Measured: Up to 24 months

  9. Phase 1 and 2: Disease control rate (DCR)

    Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks

    Measured: Up to 24 months

  10. Phase 1 and 2: Time to response (TTR)

    Time from the first dose of investigational product until the first documentation of OR

    Measured: Up to 24 months

  11. Phase 1 and 2: Overall survival (OS)

    Time from the first dose of BA3021 treatment until death due to any cause

    Measured: Up to 24 months

  12. Phase 1 and 2: Tumor size

    Percent change from baseline in tumor size

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start27 Jun 2018
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504488
Sponsor's protocol ID
BA3021-001
Status last verified
Jan 2025
First submitted
12 Apr 2018
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAB-ROR2-ADC and PD-1 inhibitor in people with Non Small Cell Lung Cancer and Triple Negative Breast Cancer, run by BioAtla, Inc. at 59 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Spain, Poland, Greece, Taiwan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Safety Profile (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03504488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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