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

NCT06307795 · tracked via the Priya Life Science China tracker

Sponsor

Avistone Biotechnology Co., Ltd

Phase

Phase 1

Started

2024-06-24

Last updated

2026-04-17

Condition(s) studied

Locally Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

ANS014004 →

ANS014004: Varying doses of ANS014004

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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 or ROS1 alteration or NTRK alternation 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

Primary outcome measure(s)

Incidence of Adverse Events (AEs) — From the time of first dose to 28 days post last dose of ANS014004
Number of patients with adverse events by system organ class and preferred term
Incidence of Serious Adverse Events (SAEs) — From time of first dose to 28 days post last dose of ANS014004
Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol — From time of first dose of ANS014004 to end of DLT period (approximately 30 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of baseline laboratory finding, ECG and vital signs changes — From time of first dose to 28 days post last dose of ANS014004
measured by laboratory and vital sign variables over time including change from
Proportion of patients with radiological response (ORR) — From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)）
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

Trial sites (15)

Facility	City	Region	Status
University of California, San Diego	San Diego	California	Recruiting
Sarah Cannon Research Institute	Denver	Colorado	Recruiting
Advent Health	Orlando	Florida	Recruiting
Henry Ford Health Cancer	Detroit	Michigan	Recruiting
NYU Langone Health	New York	New York	Recruiting
The University of Texas - MD Anderson Cancer Center	Houston	Texas	Recruiting
NEXT Oncology, Virginia	Fairfax	Virginia	Recruiting
Swedish Cancer Institute	Seattle	Washington	Recruiting
BC Cancer Vancouver Centre	Vancouver	British Columbia	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
Beijing Chest Hospital	Beijing	Beijing Municipality	Not Yet Recruiting
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	Not Yet Recruiting
Henan Cancer Hospital	Zhengzhou	Henan	Not Yet Recruiting
Shandong Cancer Hospital	Jinan	Shandong	Not Yet Recruiting
Shanghai Chest Hospital	Shanghai	Shanghai Municipality	Not Yet Recruiting

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Other trials for the same condition

A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors Recruiting

A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors Active, not recruiting

Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation Starting soon

PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors Recruiting

Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06307795 on ClinicalTrials.gov ↗ ← All trials in China