A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT06307795
- Lead Sponsor
- Avistone Biotechnology Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 63
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
- With a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, MET fusion)
- Active infection including tuberculosis and HBV, HCV or HIV
- Known active or untreated CNS metastases
- Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
- Participants with serious cardiovascular or cerebrovascular diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ANS014004 Monotherapy ANS014004 Part 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004. Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) From the time of first dose to 28 days post last dose of ANS014004 Number of patients with adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol From time of first dose of ANS014004 to end of DLT period (approximately 30 days) Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of Serious Adverse Events (SAEs) From time of first dose to 28 days post last dose of ANS014004 Number of patients with serious adverse events by system organ class and preferred term
Incidence of baseline laboratory finding, ECG and vital signs changes From time of first dose to 28 days post last dose of ANS014004 measured by laboratory and vital sign variables over time including change from
Proportion of patients with radiological response (ORR) From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)） 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
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max) From date of first dose up until 28 days post last dose Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Duration of Response (DoR) From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
Disease Control Rate (DCR) From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression
Progression free Survival (PFS) rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years) The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Objective Response Rate (ORR) From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) 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)
Overall Survival (OS) From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years) The time from the date of the first dose of study treatment until death due to any cause
Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC) From date of first dose up until 28 days post last dose Measurement of PK parameters: Area under the concentration time curve (AUC)
Pharmacokinetics of ANS014004: Plasma PK concentrations From date of first dose up until 28 days post last dose Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead
Pharmacokinetics of ANS014004: Clearance From date of first dose up until 28 days post last dose Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max) From date of first dose up until 28 days post last dose Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Pharmacokinetics of ANS014004: Half-life From date of first dose up until 28 days post last dose Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Trial Locations
- Locations (6)
Research Site
🇺🇸Seattle, Washington, United States
Resarch Site
🇺🇸New York, New York, United States
Sarah Cannon Research Institute
🇺🇸Denver, Colorado, United States
Advent Health
🇺🇸Orlando, Florida, United States
The University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology, Virginia
🇺🇸Fairfax, Virginia, United States