A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- ANS014004
- Conditions
- Locally Advanced or Metastatic Solid Tumors
- Sponsor
- Avistone Biotechnology Co., Ltd.
- Enrollment
- 63
- Locations
- 15
- Primary Endpoint
- Incidence of Adverse Events (AEs)
- Status
- Recruiting
- Last Updated
- 15 days ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
ANS014004 Monotherapy
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.
Intervention: ANS014004
Outcomes
Primary Outcomes
Incidence of Adverse Events (AEs)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- 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))
- 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))
- 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))
- 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))
- Overall Survival (OS)(From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years))
- Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)(From date of first dose up until 28 days post last dose)
- Pharmacokinetics of ANS014004: Plasma PK concentrations(From date of first dose up until 28 days post last dose)
- Pharmacokinetics of ANS014004: Clearance(From date of first dose up until 28 days post last dose)
- Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)(From date of first dose up until 28 days post last dose)
- Pharmacokinetics of ANS014004: Half-life(From date of first dose up until 28 days post last dose)