Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Conditions
Keywords
ROS1/NTRK, ANS03, ROS1, NTRK
Brief summary
This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.
Interventions
DRUGANS03
ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
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: 0-2 * Life expectancy ≥ 12 weeks * Measurable disease per RECIST v1.1 * Adequate organ and marrow function as defined in the protocol * With documentation of ROS1 or NTRK alteration
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 ANS03 | 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 ANS03 | 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 ANS03 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 ANS03 | measured by laboratory and vital sign variables over time including change from baseline |
| Proportion of patients with radiological response (ORR) | From date of first dose of ANS03 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 ANS03 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 ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) | The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression |
| Disease Control Rate (DCR) | From date of first dose of ANS03 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) |
| Progression free Survival (PFS) | From date of first dose of ANS03 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 ANS03 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 ANS03: Plasma PK concentrations | From date of first dose up until 28 days post last dose | Measurement of plasma concentrations of ANS03, total antibody and total unconjugated warhead |
| Pharmacokinetics of ANS03: 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 ANS03: 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 ANS03: Time to maximum plasma concentration of the study drug (T-max) | Frame: 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 ANS03: 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 ANS03: 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
China, United States
Contacts
CONTACTAvistone Clinical Study Information Center
Outcome results
None listed