A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors
Summary
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.
Arms & interventions
- DrugANS014004
Varying doses of ANS014004
Outcome measures
Primary
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)）
Secondary
Objective Response Rate (ORR)
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)
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)
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)
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)
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
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: 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)
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)
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Clearance
Time frame: From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Half-life
Time frame: From date of first dose up until 28 days post last dose
Eligibility criteria
Study locations (8)
University of California, San Diego
San Diego, California, 92093
Sarah Cannon Research Institute
Denver, Colorado, 80218
Advent Health
Orlando, Florida, 32804
Henry Ford Health Cancer
Detroit, Michigan, 48202
NYU Langone Health
New York, New York, 10003
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology, Virginia
Fairfax, Virginia, 22031
Swedish Cancer Institute
Seattle, Washington, 98195