The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0405 in patients with select advanced solid tumors.
This is a 2-part study. The Phase 1a will consist of a dose escalation of ADRX-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors \[including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)\], 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-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRPC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Antibody Drug Conjugate targeting STEAP1
City of Hope
Duarte, California, United States
RECRUITINGUCLA
Santa Monica, California, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
Incidence of adverse events
Time frame: Until study completion (estimated 2 years)
Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405
Measured from pharmacokinetic (PK) blood samples
Time frame: Until study completion (estimated 2 years)
Measurement of trough concentration (Ctrough) of ADRX-0405
Measured from PK blood samples
Time frame: Until study completion (estimated 2 years)
Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405
Measured from PK blood samples
Time frame: Until study completion (estimated 2 years)
Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate
Measured from PK blood samples
Time frame: Until study completion (estimated 2 years)
Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405
Measured from PK blood samples
Time frame: Until study completion (estimated 2 years)
Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405
Measured from PK blood samples
Time frame: Until study completion (estimated 2 years)
Incidence of anti-drug antibody (ADA) to ADRX-0405
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University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
RECRUITINGNEXT Austin
Austin, Texas, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGMeasured from ADA blood samples
Time frame: Until study completion (estimated 2 years)
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 2 years)
ORR per Prostate Cancer Working Group 3 (PCWG3)
Percentage of subjects achieving complete response (CR) or partial response (PR)
Time frame: Until study completion (estimated 2 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 2 years)
Measurement of disease control rate (DCR)
Percentage of subjects achieving CR, PR or stable disease (SD)
Time frame: Until study completion (estimated 2 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 2 years)
Measurement of radiographic progression free survival (rPFS)
Time from the start of study drug until first radiographic documentation of PD, or death from any cause, whichever comes first
Time frame: Until study completion (estimated 2 years)
Measurement of overall survival (OS)
Time from the start of study drug until death from any cause
Time frame: Until study completion (estimated 2 years)