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

Description

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.

Conditions

Locally Advanced or Metastatic Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Locally Advanced or Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Denver

Sarah Cannon Research Institute, Denver, Colorado, United States, 80218

Orlando

Advent Health, Orlando, Florida, United States, 32804

Houston

The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

NEXT Oncology, Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 (including MET mutation, MET amplification, MET overexpression, MET fusion)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avistone Biotechnology Co., Ltd.,

Medical Director Clinical Science, STUDY_DIRECTOR, Beijing Avistone Biotechnology Co., Ltd.

Study Record Dates

2027-10