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

NCT06716138 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ANS03-I-01
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

Keywords

ROS1/NTRK; ANS03; 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 ANS03

• 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 ANS03

• 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 ANS03 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 baseline

  From time of first dose to 28 days post last dose of ANS03

• 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 ANS03 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 ANS03 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 ANS03 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 ANS03 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

• Progression free Survival (PFS)

  From date of first dose of ANS03 up until date of progression or death due to any cause (approximately 2 years)]

• Overall Survival (OS)

  From date of first dose of ANS03 up until the date of death due to any cause (approximately 2 years)

Study Arms (1)

ANS03 monotherapy

EXPERIMENTAL

Drug: ANS03

Interventions

ANS03 DRUG

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

ANS03 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: 0-2
• 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

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 (5)

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

RECRUITING

Research Site

Fuzhou, Fujian, China

RECRUITING

Research Site

Guangzhou, Guangdong, China

RECRUITING

Research Site

Shanghai, Shanghai Municipality, China

RECRUITING

Research Site

Chengdu, Sichuan, China

RECRUITING

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: November 29, 2024
• First Posted: December 4, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1); CN (4)