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 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: Melanoma; Head and Neck Cancer; Non Small Cell Lung Cancer; Triple Negative Breast Cancer
• Intervention / Treatment: Biological: PD-1 inhibitor; Biological: CAB-ROR2-ADC

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Assess dose limiting toxicity as defined in the protocol	Up to 24 months
Phase 1: Safety Profile	Assess maximum tolerated dose as defined in the protocol	Up to 24 months
Phase 1 and 2: Safety Profile	Frequency and severity of AEs and/or SAEs	Up to 24 months
Phase 2: Confirmed Objective Response Rate (ORR)	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	Plasma concentrations of ADC, total antibody and MMAE	Up to 24 months
Phase 1: Pharmacokinetics	Peak Plasma Concentration (Cmax)	Up to 24 months
Phase 1: Immunogenicity	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 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 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)	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)	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 from the first dose of investigational product until the first documentation of OR	Up to 24 months
Phase 1 and 2: Tumor size	Percent change from baseline in tumor size	Up to 24 months
Phase 1: Pharmacokinetics	Area under the plasma concentration versus time curve	Up to 24 months
Phase 1: Confirmed Objective Response Rate (ORR)	Proportion of patients who achieve a confirmed CR or PR	Up to 24 months
Phase 1 and 2: Overall survival (OS)	Time from the first dose of BA3021 treatment until death due to any cause	Up to 24 months

Collaborators and Investigators

• Sponsor: BioAtla, Inc.
• Investigators: Study Chair: Eric Sievers, BioAtla, Inc.

Study record dates

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: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Breast Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Melanoma; Triple Negative Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Immune Checkpoint Inhibitors
• 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