Locally Advanced or Metastatic Solid Tumors
Conditions
Keywords
ROS1, NTRK, ROS1/NTRK
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.
Interventions
DRUGANS014004
Varying doses of ANS014004
Sponsors
Avistone Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 or ROS1 alteration or NTRK alternation
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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: 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: 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: 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: 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) |
| 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: 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) |
Countries
Canada, China, United States
Contacts
CONTACTAvistone Clinical Study Information Center
STUDY_DIRECTORMedical Director Clinical Science
Beijing Avistone Biotechnology Co., Ltd.
Outcome results
None listed