Clinical trial NCT03425279: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Official title: A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Undifferentiated Pleomorphic Sarcoma
Myxofibrosarcoma
Keywords: late stage
stage 3
stage 4
cancer
undifferentiated pleomorphic sarcoma
myxofibrosarcoma
Lead sponsor: BioAtla, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

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 mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).

Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Eligibility criteria: Inclusion Criteria:

* Patients must have measurable disease.
* Age ≥ 12 years (Phase 2)
* 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 well as 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 BA3011 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.

Primary outcomes:
measure: Phase 1: Safety Profile
timeFrame: Up to 24 months
measure: Phase 1: Safety Profile
timeFrame: Up to 24 months
measure: Phase 1 and 2: Safety Profile
timeFrame: Up to 24 months
measure: Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1
timeFrame: Up to 24 months
Secondary outcomes:
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Overall response rate (ORR)
timeFrame: Up to 24 months
measure: Phase 1: Immunogenicity
timeFrame: Up to 24 months
measure: Phase 1 and 2: Duration of response (DOR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Best overall response (BOR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Disease control rate (DCR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Time to response (TTR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Overall survival (OS)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Tumor size
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Precision NextGen Oncology
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute at Health One
state: Colorado
city: Washington
country: United States
facility: Children's Research Institute
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Center of Nevada
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center at Pennsylvania Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: