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

NCT ID: NCT06307795

Last Updated: 2025-04-23

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

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced or Metastatic Solid Tumors

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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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.

Group Type EXPERIMENTAL

ANS014004

Intervention Type DRUG

Varying doses of ANS014004

Interventions

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ANS014004

Varying doses of ANS014004

Intervention Type DRUG

Eligibility Criteria

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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 (including MET mutation, MET amplification, MET overexpression, MET fusion)

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

Principal Investigators

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Medical Director Clinical Science

Role: STUDY_DIRECTOR

Beijing Avistone Biotechnology Co., Ltd.

Locations

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Research Site

San Diego, California, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Denver, Colorado, United States

Site Status RECRUITING

Advent Health

Orlando, Florida, United States

Site Status RECRUITING

Research Site

Detroit, Michigan, United States

Site Status RECRUITING

Resarch Site

New York, New York, United States

Site Status RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

NEXT Oncology, Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Research Site

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Avistone Clinical Study Information Center

Role: CONTACT

8610 84148921

Other Identifiers

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ANS014004-I-US-01

Identifier Type: -

Identifier Source: org_study_id

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