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

Avistone Biotechnology

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: ANS03

Study type: Interventional

Funder types: Industry

Identifiers

NCT06716138

ANS03-I-01

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

ANS03 monotherapy

Experimental group

Treatment:

Drug: ANS03