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

NCT ID: NCT06716138

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2029-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANS03 monotherapy

Group Type EXPERIMENTAL

ANS03

Intervention Type DRUG

ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Interventions

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ANS03

ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avistone Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Research Site

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Research Site

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Research Site

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Research Site

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Research Site

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Countries

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United States China

Central Contacts

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Avistone Clinical Study Information Center

Role: CONTACT

8610 84148921

Other Identifiers

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ANS03-I-01

Identifier Type: -

Identifier Source: org_study_id

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