The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
Conditionally active biologic anti-AXL antibody drug conjugate
PD-1 inhibitor
Phase 1: Safety Profile
Assess dose limiting toxicity as defined in the protocol
Time frame: Up to 24 months
Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol
Time frame: Up to 24 months
Phase 1 and 2: Safety Profile
Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs
Time frame: Up to 24 months
Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Plasma concentrations of ADC, total antibody and MMAE
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Peak Plasma Concentration (Cmax)
Time frame: Up to 24 months
Phase 1: Pharmacokinetics
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 24 months
Phase 1: Overall response rate (ORR)
Proportion of patients who achieve a confirmed CR or PR
Time frame: Up to 24 months
Phase 1: Immunogenicity
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The University of Arizona Cancer Center
Tucson, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, United States
Precision NextGen Oncology
Los Angeles, California, United States
UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Sarah Cannon Research Institute at Health One
Denver, Colorado, United States
Children's Research Institute
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
...and 30 more locations
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Time frame: 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
Time frame: 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
Time frame: Up to 24 months
Phase 1 and 2: Best overall response (BOR)
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Time frame: 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
Time frame: 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
Time frame: Up to 24 months
Phase 1 and 2: Overall survival (OS)
Time from the first dose of BA3011 treatment until death due to any cause
Time frame: Up to 24 months
Phase 1 and 2: Tumor size
Percent change from baseline in tumor size
Time frame: Up to 24 months