The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC 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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Conditionally active biologic anti-ROR2 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
Time frame: Up to 24 months
Phase 2: Confirmed Objective Response Rate (ORR)
Proportion of patients who achieve a confirmed CR or PR
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
Time frame: Up to 24 months
Phase 1: Confirmed Objective Response Rate (ORR)
Proportion of patients who achieve a confirmed CR or PR
Time frame: Up to 24 months
Phase 1: Immunogenicity
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
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University of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope - Duarte
Duarte, California, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
California Research Institute
Los Angeles, California, United States
USC Norris
Los Angeles, California, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
American Institute of Research
Whittier, California, United States
University of Colorado
Aurora, Colorado, United States
Sarah Cannon Research Institute at Health One
Denver, Colorado, United States
...and 49 more locations
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 (OR)
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 BA3021 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