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

NCT06307795 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ANS014004-I-US-01
• Study Type: interventional
• Target: 63
• Locations: 3 countries
• Sites: 15

Brief Summary

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

Keywords

ROS1; NTRK; ROS1/NTRK

Outcome Measures

Primary Outcomes (5)

• Incidence of Adverse Events (AEs)

  Number of patients with adverse events by system organ class and preferred term

  From the time of first dose to 28 days post last dose of ANS014004

• Incidence of Serious Adverse Events (SAEs)

  Number of patients with serious adverse events by system organ class and preferred term

  From time of first dose to 28 days post last dose of ANS014004

• Incidence of dose-limiting toxicities (DLT) as defined in the protocol

  Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

  From time of first dose of ANS014004 to end of DLT period (approximately 30 days)

• Incidence of baseline laboratory finding, ECG and vital signs changes

  measured by laboratory and vital sign variables over time including change from

  From time of first dose to 28 days post last dose of ANS014004

• Proportion of patients with radiological response (ORR)

  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

  From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）

Secondary Outcomes (11)

• Objective Response Rate (ORR)

  From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

• Duration of Response (DoR)

  From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

• Disease Control Rate (DCR)

  From date of first dose of ANS014004 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

• Progression free Survival (PFS)

  rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)

• Overall Survival (OS)

  From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)

Study Arms (1)

ANS014004 Monotherapy

EXPERIMENTAL

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.

Drug: ANS014004

Interventions

ANS014004 DRUG

Varying doses of ANS014004

ANS014004 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avistone Biotechnology Co., Ltd.: lead

Study Sites (15)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

RECRUITING

Advent Health

Orlando, Florida, 32804, United States

RECRUITING

Henry Ford Health Cancer

Detroit, Michigan, 48202, United States

RECRUITING

NYU Langone Health

New York, New York, 10003, United States

RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology, Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98195, United States

RECRUITING

BC Cancer Vancouver Centre

Vancouver, British Columbia, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Beijing Chest Hospital

Beijing, Beijing Municipality, 101149, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150010, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Study Officials

• Medical Director Clinical Science

  Beijing Avistone Biotechnology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Avistone Clinical Study Information Center

CONTACT

8610 84148921; information.center@avistonebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 13, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (8); CN (5)