The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select advanced solid tumors.
This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0706 in patients with urothelial cancer, triple negative breast cancer, and cervical cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Antibody drug conjugate targeting Nectin-4
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Incidence of adverse events
Time frame: Until study completion (estimated 3 years)
Measurement of maximum plasma concentration (Cmax) of ADRX-0706
Measured from pharmacokinetic (PK) blood samples
Time frame: Until study completion (estimated 3 years)
Measurement of trough concentration (Ctrough) of ADRX-0706
Measured from PK blood samples
Time frame: Until study completion (estimated 3 years)
Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706
Measured from PK blood samples
Time frame: Until study completion (estimated 3 years)
Measurement of terminal half-life (t1/2) of ADRX-0706
Measured from PK blood samples
Time frame: Until study completion (estimated 3 years)
Measurement of systemic clearance (CL) of ADRX-0706
Measured from PK blood samples
Time frame: Until study completion (estimated 3 years)
Measurement of volume of distribution at steady state (Vss) of ADRX-0706
Measured from PK blood samples
Time frame: Until study completion (estimated 3 years)
Incidence of anti-drug antibodies (ADA)
Measured from ADA blood samples
Time frame: Until study completion (estimated 3 years)
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
The Ohio State University Wexner Medical Center
Hilliard, Ohio, United States
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Measurement of objective response rate (ORR) per RECIST 1.1
Percentage of subjects achieving complete response (CR) or partial response (PR)
Time frame: Until study completion (estimated 3 years)
Measurement of duration of response (DOR)
Time from first response until first evidence of disease progression (PD) or death from any cause
Time frame: Until study completion (estimated 3 years)
Measurement of disease control rate (DCR)
Percentage of subjects achieving CR, PR or stable disease (SD)
Time frame: Until study completion (estimated 3 years)
Measurement of progression free survival (PFS)
Time from the start of study drug until first evidence of PD or death from any cause
Time frame: Until study completion (estimated 3 years)
Measurement of overall survival (OS)
Time from the start of study drug until death from any cause
Time frame: Until study completion (estimated 3 years)