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

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504488
• Other study ID #: BA3021-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 27, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: BioAtla, Inc.
• Contact: BioAtla Medical Affairs
• Phone: 8585580708
• Email: medicalaffairs[@]bioatla.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Melanoma
• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Biological:
• CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
• PD-1 inhibitor
PD-1 inhibitor

Locations

Country	Name	City	State
Germany	Jeanette Natschke	Berlin
Germany	Norman Golchert	Berlin
Germany	Thea Resch	Essen
Germany	Asklepios Clinical Center Harburg	Hamburg
Greece	"Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit	Athens
Greece	HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit	Athens
Greece	Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department	Piraeus
Greece	Bioclinic Thessaloniki, ?ncology Department	Thessaloniki
Greece	European Interbalkan Medical Center, ?ncology Department	Thessaloniki
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Italy	"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."	Genoa	Liguria
Italy	Santa Maria delle Croci Hospital of Ravenna	Ravenna	Emilia-Romagna
Poland	Polish Mother's Memorial Hospital-Research Institute	Lodz	Lodzkie
Poland	Institute of Genetics and Immunology GENIM LCC in Lublin	Lublin	Lubelskie
Poland	MED-Polonia, Sp. z o.o. (LLC)	Poznan	Wielkopolskie
Poland	Beata Glogowska	Tomaszów Mazowiecki	Lodzkie
Poland	Malgorzata Kozlik	Warsaw	Mazowieckie
Spain	Anna Ramos Luna	Barcelona	Catalonia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia
Spain	Hospital del Mar	Barcelona	Catalonia
Spain	University Clinic of Navarra - Madrid	Madrid
Spain	University Hospital 12 de Octubre	Madrid
Spain	University Hospital Nuestra Senora de Valme	Sevilla	Andalusia
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	LinKou Chang Gung Memorial Hospital	Taoyuan City
United States	Augusta University - Georgia Cancer Center	Augusta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Hematology/Oncology Clinic	Baton Rouge	Louisiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park	Buffalo	New York
United States	Medical University of South Carolina- Hollings Cancer Center	Charleston	South Carolina
United States	The Christ Hospital	Cincinnati	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Sarah Cannon Research Institute at Health One	Denver	Colorado
United States	City of Hope - Duarte	Duarte	California
United States	Florida Cancer Specialists & Research Institute	Fleming Island	Florida
United States	Florida Cancer Specialists & Research Institute	Fort Myers	Florida
United States	Memorial Cancer Institute (MCI)	Hollywood	Florida
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of California, San Diego (UCSD) - Moores Cancer Center	La Jolla	California
United States	Comprehensive Cancer Care of Nevada	Las Vegas	Nevada
United States	OptumCare Cancer Care	Las Vegas	Nevada
United States	Baptist Health Systems	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	California Research Institute	Los Angeles	California
United States	USC Norris	Los Angeles	California
United States	Norton Cancer Institute, Brownsboro Hospital Campus	Louisville	Kentucky
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	UC Irvine Medical Center - Chao Family Comprehensive Cancer Center	Orange	California
United States	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina
United States	UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Florida Cancer Specialist - North	Saint Petersburg	Florida
United States	University of Utah - Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California
United States	Memorial Sloan-Kettering Cancer Center	Tampa	Florida
United States	Moffitt Cancer Center	Tampa	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	American Institute of Research	Whittier	California
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
BioAtla, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Hong Kong,  Italy,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Safety Profile	Assess dose limiting toxicity as defined in the protocol	Up to 24 months
Primary	Phase 1: Safety Profile	Assess maximum tolerated dose as defined in the protocol	Up to 24 months
Primary	Phase 1 and 2: Safety Profile	Frequency and severity of AEs and/or SAEs	Up to 24 months
Primary	Phase 2: Confirmed Objective Response Rate (ORR)	Proportion of patients who achieve a confirmed CR or PR	Up to 24 months
Secondary	Phase 1: Pharmacokinetics	Plasma concentrations of ADC, total antibody and MMAE	Up to 24 months
Secondary	Phase 1: Pharmacokinetics	Peak Plasma Concentration (Cmax)	Up to 24 months
Secondary	Phase 1: Pharmacokinetics	Area under the plasma concentration versus time curve	Up to 24 months
Secondary	Phase 1: Confirmed Objective Response Rate (ORR)	Proportion of patients who achieve a confirmed CR or PR	Up to 24 months
Secondary	Phase 1: Immunogenicity	The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)	Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Phase 1 and 2: Tumor size	Percent change from baseline in tumor size	Up to 24 months