A Study to Investigate ANS014004 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
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
ANS014004
DrugVarying doses of ANS014004
Treatment groups
63 Participants
are divided into 1 treatment groupGroup A: ANS014004 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 ANS0140042
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 ANS0140043
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)4
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 ANS014004Secondary 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 ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)2
Duration of Response (DoR)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
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)3
Disease Control Rate (DCR)
From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression
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)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
rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)Sponsors and contacts
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Source ClinicalTrials.gov