This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Varying doses of ANS014004
University of California, San Diego
San Diego, California, United States
RECRUITINGSarah Cannon Research Institute
Denver, Colorado, United States
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame: From the time of first dose to 28 days post last dose of ANS014004
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of first dose to 28 days post last dose of ANS014004
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame: From time of first dose of ANS014004 to end of DLT period (approximately 30 days)
Incidence of baseline laboratory finding, ECG and vital signs changes
measured by laboratory and vital sign variables over time including change from
Time frame: From time of first dose to 28 days post last dose of ANS014004
Proportion of patients with radiological response (ORR)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1
Time frame: From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）
Objective Response Rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)
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Advent Health
Orlando, Florida, United States
RECRUITINGHenry Ford Health Cancer
Detroit, Michigan, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGThe University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Oncology, Virginia
Fairfax, Virginia, United States
RECRUITINGSwedish Cancer Institute
Seattle, Washington, United States
RECRUITINGBC Cancer Vancouver Centre
Vancouver, British Columbia, Canada
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITING...and 5 more locations
Time frame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DoR)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
Time frame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression
Time frame: From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Time frame: rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause
Time frame: From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of ANS014004: Plasma PK concentrations
Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Clearance
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Half-life
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Time frame: From date of first dose up until 28 days post last dose