Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06307795

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Locally Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BC Cancer Vancouver Centre, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANS014004

Drug

Varying doses of ANS014004

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  1. Objective Response Rate (ORR)

    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)

    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)

  2. Duration of Response (DoR)

    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)

    The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)

  3. Disease Control Rate (DCR)

    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)

    From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression

  4. Progression free Survival (PFS)

    Time frame: 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

  5. Overall Survival (OS)

    Time frame: 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

  6. Pharmacokinetics of ANS014004: Plasma PK concentrations

    Time frame: From date of first dose up until 28 days post last dose

    Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead

  7. Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)

    Time frame: From date of first dose up until 28 days post last dose

    Measurement of PK parameters: Area under the concentration time curve (AUC)

  8. Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)

    Time frame: 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)

  9. Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)

    Time 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)

  10. Pharmacokinetics of ANS014004: Clearance

    Time frame: 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)

  11. Pharmacokinetics of ANS014004: Half-life

    Time frame: From date of first dose up until 28 days post last dose

    Measurement of PK parameters: Terminal elimination half-life (t 1/2)

Study contacts

Contact information is provided by the study sponsor or research team.

Avistone Clinical Study Information Center

CONTACT

[email protected]

8610 84148921

Sponsors and collaborators

Lead sponsor

Avistone Biotechnology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2024
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.