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

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: ANS014004

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Avistone Clinical Study Information Center; Phone Number: 8610 84148921; Email: information.center@avistonebio.com

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute
      • Contact: MD
  • Florida
    • Orlando, Florida, United States, 32804
      • Advent Health
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas - MD Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT Oncology, Virginia
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Univ. of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANS014004 Monotherapy; 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; Varying doses of ANS014004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)	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)	The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)	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	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)	The time from first dose until RECIST 1.1 defined disease progression or death due to any cause	rom date of first dose of ANS014004 up until date of progression or death due to any cause (approximately 2 years)
Overall Survival (OS)	The time from the date of the first dose of study treatment until death due to any cause	From date of first dose of ANS014004 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of ANS014004: Plasma PK concentrations	Measurement of plasma concentrations of ANS014004, total antibody and total unconjugated warhead	From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Area under the concentration time curve (AUC)	Measurement of PK parameters: Area under the concentration time curve (AUC)	From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Maximum plasma concentration of the study drug (C-max)	Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)	From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Time to maximum plasma concentration of the study drug (T-max)	Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)	From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Clearance	Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)	From date of first dose up until 28 days post last dose
Pharmacokinetics of ANS014004: Half-life	Measurement of PK parameters: Terminal elimination half-life (t 1/2)	From date of first dose up until 28 days post last dose

Collaborators and Investigators

• Sponsor: Avistone Biotechnology Co., Ltd.
• Investigators: Study Director: Medical Director Clinical Science, Beijing Avistone Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ANS014004-I-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No