A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvistone Biotechnology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
Life expectancy ≥ 12 weeks
Measurable disease per RECIST v1.1
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ANS03
DrugANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
Treatment groups
96 Participants
are divided into 1 treatment groupGroup A: ANS03 monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 ANS032
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 ANS033
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 ANS03 to end of DLT period (approximately 30 days)4
Incidence of baseline laboratory finding, ECG and vital signs changes
measured by laboratory and vital sign variables over time including change from baseline
Time frame
From time of first dose to 28 days post last dose of ANS03Secondary outcomes
1
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)
Time frame
From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)2
Duration of Response (DoR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Time frame
From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)3
Disease Control Rate (DCR)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
Time frame
From date of first dose of ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)4
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Time frame
From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]Sponsors and contacts
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Source ClinicalTrials.gov