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

Avistone Biotechnology

Status and phase: Enrolling; Phase 1

Conditions: Locally Advanced or Metastatic Solid Tumors

Treatments: Drug: ANS014004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06307795

ANS014004-I-US-01

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

ANS014004 Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: ANS014004