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

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307795
• Other study ID #: ANS014004-I-US-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: October 2027

Study information

• Verified date: March 2024
• Source: Avistone Biotechnology Co., Ltd.
• Contact: Avistone Clinical Study Information Center
• Phone: 8610 84148921
• Email: information.center[@]avistonebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: October 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• ANS014004
Varying doses of ANS014004

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute	Denver	Colorado
United States	NEXT Oncology, Virginia	Fairfax	Virginia
United States	The University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Advent Health	Orlando	Florida
United States	Univ. of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Avistone Biotechnology Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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