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NCT06716138 | RECRUITING | Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:

Avistone Biotechnology Co., Ltd.

Brief Summary:

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.

Condition or disease

Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Intervention/treatment

ANS03

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 96 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Actual Study Start Date : 2025-03-06
Estimated Primary Completion Date : 2027-12-30
Estimated Study Completion Date : 2029-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age ≥ 18 years
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
  • * Life expectancy ≥ 12 weeks
  • * Measurable disease per RECIST v1.1
  • * Adequate organ and marrow function as defined in the protocol
  • * With documentation of ROS1 or NTRK alteration
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
A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

Location Details

NCT06716138

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, New York

Research Site

New York, New York, United States, 10022

NOT YET RECRUITING

China, Fujian

Research Site

F U-axis, Fujian, China,

NOT YET RECRUITING

China, Guangdong

Research Site

Guangzhou, Guangdong, China,

RECRUITING

China, Shanghai Municipality

Research Site

Shanghai, Shanghai Municipality, China,

NOT YET RECRUITING

China, Shanghai Municipality

Research Site

Shanghai, Shanghai Municipality, China,

NOT YET RECRUITING

China, Sichuan

Research Site

Chengdu, Sichuan, China,